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Trials (University Hospital of Umeå - Norrland University Hospital)
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<span style="display:none">forresearchers</span> <span style="display:none">forpatients</span> <span style="display:none">forproviders</span> <span style="display:none">swedencountry</span> Go back to [[University Hospital of Umeå - Norrland University Hospital]] page '''NCTID''': NCT01347697 '''Title''': Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer '''Study Summary''': The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: * a technique using a gluteus maximus myocutaneous flap or * a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project. '''Sponsor''': Umeå University '''Intervention''': Reconstruction with an acellular porcine dermal collagen implant (biological mesh) '''Start Date''': 2011-09-05 '''Last Updated''': 2023-05-03 '''Number of Patients''': 91 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Rectal Cancer '''NCTID''': NCT02919787 '''Title''': Nordic Pancreatic Cancer Trial (NorPACT) - 1 '''Study Summary''': This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection '''Sponsor''': Oslo University Hospital '''Intervention''': 5-FU '''Start Date''': 2016-09 '''Last Updated''': 2023-02-10 '''Number of Patients''': 140 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Pancreatic Cancer '''NCTID''': NCT03326791 '''Title''': Aspirin in Colorectal Cancer Liver Metastases '''Study Summary''': The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM). Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo for a period of 3 years or till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness. '''Sponsor''': Oslo University Hospital '''Intervention''': Acetylsalicylic acid '''Start Date''': 2017-12-15 '''Last Updated''': 2023-12-13 '''Number of Patients''': 466 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Colorectal Cancer Liver Metastases '''NCTID''': NCT03206671 '''Title''': Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents '''Study Summary''': The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents. The following primary study questions are going to be analyzed: * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. * the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab. Secondary study questions will address * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment * adverse event and severe adverse event profile * inter-individual variability of rituximab response * role of different mechanisms of action of rituximab in advanced B-NHL/B-AL '''Sponsor''': University Hospital Muenster '''Intervention''': Rituximab window '''Start Date''': 2017-08-03 '''Last Updated''': 2023-12-11 '''Number of Patients''': 650 '''Recruitment Status''': RECRUITING '''Condition''': Mature B-cell Non-Hodgkin Lymphoma '''NCTID''': NCT04243005 '''Title''': Supramarginal Resection in Glioblastoma '''Study Summary''': Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment. The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is “maximum safe resection of the contrast enhancing tumor”, but this may in selected cases be extended to simply “maximum safe resection” tailored to the patient and extent of disease at hand. Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole. Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma. '''Sponsor''': St. Olavs Hospital '''Intervention''': Supramarginal resection '''Start Date''': 2020-07-01 '''Last Updated''': 2023-12-15 '''Number of Patients''': 90 '''Recruitment Status''': RECRUITING '''Condition''': Glioblastoma '''NCTID''': NCT01725204 '''Title''': Safety and Efficacy of Pegylated IFN-alpha 2B Added to Dasatinib in Newly Diagnosed Chronic Phase Myeloid Leukemia '''Study Summary''': Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors (TKI). However, a few patients will be cured with TKIs alone, and thus need continued life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate is higher with second generation TKIs compared with imatinib. Some experience with drug discontinuation in CMR has been derived from a few small studies, most notably the French STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log reduction in molecular response) can stop imatinib without relapse, indicating possible cure. To increase the non-relapse rate is of major importance. To achieve a permanent “cure” without stem cell transplantation is presently the most relevant goal of clinical studies in CML. The investigators hypothesize that to significantly increase cure rates in CML, therapy should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second generation TKIs may have a more profound effect on the stem cell pool as compared to imatinib. This is assessed in our current randomized study with a reduction in leukemic stem cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent immunomodulatory and antiproliferative mode of action, and has also activity in stem cells. Pegylated IFN in combination with imatinib results in improved therapy responses as compared to imatinib monotherapy. This advantage may translate into higher cure rates. Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and induces immunological effects that are different from those of IFN. Both of these drugs may have immunological adverse-effects when used as a monotherapy. However, immunological adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a clinical study. '''Sponsor''': Norwegian University of Science and Technology '''Intervention''': Dasatinib + PegIFN '''Start Date''': 2012-09 '''Last Updated''': 2017-09-25 '''Number of Patients''': 40 '''Recruitment Status''': COMPLETED '''Condition''': Leukemia, Myeloid, Chronic-Phase '''NCTID''': NCT02568839 '''Title''': Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer '''Study Summary''': The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations. '''Sponsor''': Thomas Hatschek '''Intervention''': docetaxel + trastuzumab sc + pertuzumab '''Start Date''': 2014-11 '''Last Updated''': 2020-08-13 '''Number of Patients''': 202 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Early-Stage Breast Carcinoma '''NCTID''': NCT01152606 '''Title''': A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin '''Study Summary''': This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre’s medical records for up to 5 years or death. '''Sponsor''': Hoffmann-La Roche '''Intervention''': trastuzumab [Herceptin] '''Start Date''': 2007-08-30 '''Last Updated''': 2018-01-25 '''Number of Patients''': 3942 '''Recruitment Status''': COMPLETED '''Condition''': Breast Cancer '''NCTID''': NCT04612907 '''Title''': Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer '''Study Summary''': de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested. '''Sponsor''': Umeå University '''Intervention''': Moderate hypo-fractionation '''Start Date''': 2022-10-31 '''Last Updated''': 2022-11-04 '''Number of Patients''': 420 '''Recruitment Status''': RECRUITING '''Condition''': Prostate Cancer '''NCTID''': NCT02432846 '''Title''': Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) '''Study Summary''': The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients. '''Sponsor''': Mendus '''Intervention''': Intuvax (INN: ilixadencel) '''Start Date''': 2015-04 '''Last Updated''': 2022-08-22 '''Number of Patients''': 88 '''Recruitment Status''': COMPLETED '''Condition''': Renal Cell Carcinoma, Metastatic '''NCTID''': NCT04114825 '''Title''': Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer '''Study Summary''': This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V). '''Sponsor''': RhoVac APS '''Intervention''': RV001V '''Start Date''': 2019-11-19 '''Last Updated''': 2021-09-28 '''Number of Patients''': 180 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Prostate Cancer Recurrent '''NCTID''': NCT00300729 '''Title''': Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy '''Study Summary''': The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics). '''Sponsor''': University Hospital, Linkoeping '''Intervention''': Celecoxib '''Start Date''': 2006-05 '''Last Updated''': 2009-06-30 '''Number of Patients''': 319 '''Recruitment Status''': UNKNOWN '''Condition''': Non-Small Cell Lung Cancer '''NCTID''': NCT03116412 '''Title''': A Randomized Trial to Assess the Role of Imaging During Follow up After Radical Surgery of High Risk Melanoma '''Study Summary''': It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence. '''Sponsor''': Uppsala University '''Intervention''': CT or PET scans '''Start Date''': 2017-06-08 '''Last Updated''': 2019-04-18 '''Number of Patients''': 1300 '''Recruitment Status''': RECRUITING '''Condition''': Malignant Melanoma '''NCTID''': NCT02914873 '''Title''': SPCG17: Prostate Cancer Active Surveillance Trigger Trial '''Study Summary''': A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality. '''Sponsor''': Uppsala University '''Intervention''': Active surveillance '''Start Date''': 2016-10 '''Last Updated''': 2022-12-16 '''Number of Patients''': 2000 '''Recruitment Status''': RECRUITING '''Condition''': Prostate Cancer '''NCTID''': NCT01358877 '''Title''': A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer '''Study Summary''': This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). '''Sponsor''': Hoffmann-La Roche '''Intervention''': 5-Fluorouracil '''Start Date''': 2011-11-08 '''Last Updated''': 2023-12-22 '''Number of Patients''': 4804 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Breast Cancer '''NCTID''': NCT02111577 '''Title''': Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer '''Study Summary''': The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer. '''Sponsor''': SOTIO a.s. '''Intervention''': DCVAC/PCa '''Start Date''': 2014-05-26 '''Last Updated''': 2021-04-06 '''Number of Patients''': 1182 '''Recruitment Status''': COMPLETED '''Condition''': Metastatic Castration-resistant Prostate Cancer '''NCTID''': NCT02102477 '''Title''': Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer '''Study Summary''': This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate. One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery. A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted. '''Sponsor''': Olof Akre '''Intervention''': Prostatectomy/Surgery '''Start Date''': 2014-10 '''Last Updated''': 2022-03-31 '''Number of Patients''': 1200 '''Recruitment Status''': RECRUITING '''Condition''': Prostatic Neoplasms '''NCTID''': NCT05797558 '''Title''': Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment '''Study Summary''': This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism ,randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone. '''Sponsor''': Göteborg University '''Intervention''': Unilateral adrenalectomy '''Start Date''': 2023-04-28 '''Last Updated''': 2023-05-01 '''Number of Patients''': 80 '''Recruitment Status''': RECRUITING '''Condition''': Primary Hyperaldosteronism Due to Adrenal Adenoma '''NCTID''': NCT04067180 '''Title''': Randomized Clinical Study Assessing Haplo vs. URD in AML '''Study Summary''': This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT. Background: A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly. The Study: Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs. After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today. The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years. '''Sponsor''': Karolinska Institutet '''Intervention''': allogeneic stem cell transplantation with a haplo-identical family donor graft '''Start Date''': 2019-11-12 '''Last Updated''': 2023-04-05 '''Number of Patients''': 18 '''Recruitment Status''': TERMINATED '''Condition''': Acute Myeloid Leukemia '''NCTID''': NCT01048034 '''Title''': Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) '''Study Summary''': Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk MDS. This study will evaluate the effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1) or low risk CMML. Included patients should first have failed, or considered not being eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to transfusion independency in this group of patients. Those patients who do not respond to treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO. '''Sponsor''': Nordic MDS Group '''Intervention''': Azacitidine '''Start Date''': 2010-01 '''Last Updated''': 2013-10-29 '''Number of Patients''': 30 '''Recruitment Status''': COMPLETED '''Condition''': Myelodysplastic Syndrome '''NCTID''': NCT06223698 '''Title''': Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer '''Study Summary''': Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice. The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios: * In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen. * In postmenopausal women at diagnosis. '''Sponsor''': Region Örebro County '''Intervention''': Letrozole '''Start Date''': 2024-05-02 '''Last Updated''': 2024-01-25 '''Number of Patients''': 3832 '''Recruitment Status''': NOT_YET_RECRUITING '''Condition''': Breast Cancer '''NCTID''': NCT02451111 '''Title''': Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma '''Study Summary''': Follicular lymphomas FL has been traditionally approached either by an initial watch and wait policy in the asymptomatic patient, or with single agent treatments with the purpose of maintaining a good quality of life for a prolonged time.The combination of rituximab and ibrutinib has been tested in clinical trials and appeared to be well tolerated and active. Since ibrutinib seems to achieve better results when administered for prolonged time as shown in CLL, the investigators have chosen to compare its combination with rituximab to the prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03 trial. The aim of the study is to investigate the efficacy, safety and tolerability of the treatment combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need of therapy. '''Sponsor''': Swiss Group for Clinical Cancer Research '''Intervention''': Ibrutinib '''Start Date''': 2015-11-06 '''Last Updated''': 2023-03-08 '''Number of Patients''': 190 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Follicular Lymphoma '''NCTID''': NCT00498836 '''Title''': Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma '''Study Summary''': Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until complete response or disease worsening/progressing. '''Sponsor''': Clavis Pharma '''Intervention''': CP-4055 '''Start Date''': 2007-03 '''Last Updated''': 2013-09-12 '''Number of Patients''': 18 '''Recruitment Status''': COMPLETED '''Condition''': Malignant Melanoma '''NCTID''': NCT02647099 '''Title''': Adjuvant Low Dose Aspirin in Colorectal Cancer '''Study Summary''': ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled, biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in PI3K pathway can significantly improve survival if treated with low dose aspirin. '''Sponsor''': Anna Martling '''Intervention''': Acetylsalicylic acid '''Start Date''': 2016-04-07 '''Last Updated''': 2023-12-19 '''Number of Patients''': 600 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Colorectal Cancer '''NCTID''': NCT00418899 '''Title''': Gliogene: Brain Tumor Linkage Study '''Study Summary''': The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family’s genes and increase the risk of developing gliomas. Objectives: We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to identify susceptibility genes in high-risk familial brain tumor pedigrees using the most sophisticated genetic analysis methods available. To address our hypothesis, we propose the following specific aims: Aim 1: Establish a cohort of 400 high-risk pedigrees for genetic linkage analysis. To date, we have identified and collected biologic samples from 20 high-risk families that have met our criteria of 2 or more relatives diagnosed with a brain tumor. From the 15 centers in the United States and Europe, we will screen and obtain epidemiologic data from approximately 17,080 gliomas cases to identify a target of 400 families for genetic analysis. We will establish a cohort of the first and second-degree relatives from these glioma cases to obtain new knowledge about how cancer aggregates in glioma families. We will also acquire biospecimens (blood and tumor tissue), and risk factor data from relevant family members. Aim 2: Identify candidate regions linked to familial brain tumors. To strengthen evidence of linkage to regions found in our preliminary analysis and to identify additional regions linked to brain tumors, we will genotype informative glioma pedigrees identified in aim 1 using Affymetrix 10K GeneChip with markers spaced throughout the genome, and conduct a genome-wide multipoint linkage scan with these markers. Aim 3: Fine map the regions established in Aim 2 by genotyping selected SNPs from genome databases. We will attempt to further refine the regions identified in Aim 2 to less than 1cM by using approximately 1,500 - 2,000 carefully selected SNPs. The prioritization of regions will be based on a combination of the strength of evidence for linkage from families of various ethnic backgrounds and the presence of obvious candidate genes. '''Sponsor''': M.D. Anderson Cancer Center '''Intervention''': Questionnaire '''Start Date''': 2004-02-12 '''Last Updated''': 2020-12-31 '''Number of Patients''': 17080 '''Recruitment Status''': UNKNOWN '''Condition''': Brain Tumor <span style="display:none">hasCancerType::C00-D48: All neoplasms</span> <span style="display:none">hasCancerType::C00-C97: All cancer types</span> <span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span> <span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span> <span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span> <span style="display:none">hasCancerType::C40-C41: Bone cancers</span> <span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span> <span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span> <span style="display:none">hasCancerType::C50: Breast cancer</span> <span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span> <span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span> <span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span> <span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span> <span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span> <span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span> <span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span> <span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span> <span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span> <span style="display:none">hasCancerType::D10-D36: Benign tumour</span> <span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span> <span style="display:none">hasCancerType::unknown</span>
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