Trials (Azienda Unità Sanitaria Locale di Reggio Emilia - IRCCS Istituto in Tecnologie Avanzate e Modelli Assistenziali in Oncologia)

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NCTID: NCT05929222

Title: Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi 
Study Summary: Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinotuzumab. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Radiotherapy 
Start Date: 2024-01 
Last Updated: 2023-09-08 
Number of Patients: 190 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Follicular Lymphoma 

NCTID: NCT05634200

Title: Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan 
Study Summary: Conflicting evidence exist in the literature on the utility of bronchoscopy in patients with haemoptysis and negative on-diagnostic chest CT scan.  The primary aim of this prospective, observational, multicenter study is to evaluate the utility of bronchoscopy in patients with haemoptysis and negative on-diagnostic CT scans. Secondary aims are related to the utility of bronchoscopy to detect occult malignancies, the source of the bleeding and the clinical features of the cohort 
Sponsor: University of Milan 
Intervention: Bronchoscopy 
Start Date: 2022-10-01 
Last Updated: 2023-08-01 
Number of Patients: 150 
Recruitment Status: RECRUITING 
Condition: Hemoptysis 

NCTID: NCT01837693

Title: Cervical Cancer Prevention: From DNA to mRNA? - New Technologies for Cervical Cancer Screening 2 
Study Summary: In industrialized countries, cervical cancer is a well controlled disease thanks to the diffusion of Pap test and, in particular, to organized screening programs, which are able to detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of cervical cancer, so a new screening test based on the identification of high risk (HR) HPV types has been developed(HPV DNA test). This test has demonstrated to be more effective than cytology in reducing the incidence and the mortality of cervical cancer, but it is less specific, so the use of a test triage is necessary to reduce the number of colposcopies and the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions). Until now, the triage test used is the cytology (Pap test).  Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN, targeting the molecular alterations strictly associated to transformation rather than simply detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest reduction of sensitivity for high-grade lesions.  This is a multicenter randomised trial nested into some Italian screening programs based on the use of HPV DNA test as primary test.  All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16. Women with positive cytology will be referred to colposcopy, while women with negative cytology will be randomized into two arms.  This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as a primary screening test with direct sending in colposcopy.  In particular the main objectives are:  * Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA positive test and mRNA or p16 negative. * Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of DNA, with direct sending in colposcopy * Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or p16 compared to the direct sending in colposcopy in women with HPV DNA test positive.  Secondary objectives are:  * to assess the feasibility of mRNA testing in primary screening * to validate the sample techniques for the new tests * to standardize quality controls for the the new tests 
Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia 
Intervention: Experimental: immediate colposcopy 
Start Date: 2013-06 
Last Updated: 2013-04-23 
Number of Patients: 60000 
Recruitment Status: UNKNOWN 
Condition: Precancerous Conditions 

NCTID: NCT04461808

Title: Tomosynthesis as Primary Test for Breast Cancer Screening 
Study Summary: Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. 
Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia 
Intervention: tomosynthesis + synthetic 2D 
Start Date: 2019-07-15 
Last Updated: 2023-09-21 
Number of Patients: 10156 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04740918

Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) 
Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2021-06-07 
Last Updated: 2023-11-18 
Number of Patients: 96 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT04718844

Title: A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome 
Study Summary: This study will investigate the safety and tolerability of SLN124 in patients with Thalassaemia or patients with Very Low- and Low-risk Myelodysplastic Syndrome (MDS) after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 7 cohorts of 56 patients with Thalassaemia and up to 7 cohorts of 56 patients with MDS will be enrolled. Each subject will receive single or multiple doses of SLN124 or placebo given by subcutaneous (s.c) injection. 
Sponsor: Silence Therapeutics plc 
Intervention: SLN124 
Start Date: 2021-04-14 
Last Updated: 2023-08-14 
Number of Patients: 44 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-transfusion-dependent Thalassemia 

NCTID: NCT06051136

Title: Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer 
Study Summary: In Italy, the incidence of lung cancer for the year 2020 has been estimated at about 41.000 new diagnoses. Patients with lung cancer experience debilitating symptoms caused by the disease itself and cancer treatments, such as dyspnea and fatigue, which reduce physical function and quality of life (QoL). It is estimated that 90% of patients undergoing chemotherapy and 57% of patients undergoing lung resection suffer of Cancer-Related Fatigue (CRF).  Previous studies have shown that educational interventions and aerobic and resistance exercise are effective in improving CRF and QoL in patients with lung cancer. However, to date the optimal dose, mode and timing to deliver the intervention during the care pathway for lung cancer patients is unknown. Tolerability and frequency of cancer treatment could be a barrier to adherence to the intervention. Therefore, this study aims to evaluate the feasibility of a rehabilitation intervention aimed at improving CRF with respect to timing of delivery: early vs delayed rehabilitation in lung cancer patients. 
Sponsor: Arcispedale Santa Maria Nuova-IRCCS 
Intervention: Pulmonary rehabilitation 
Start Date: 2023-02-28 
Last Updated: 2023-09-22 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Lung Cancer 

NCTID: NCT05296798

Title: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) 
Study Summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Phesgo 
Start Date: 2022-07-04 
Last Updated: 2023-11-28 
Number of Patients: 812 
Recruitment Status: RECRUITING 
Condition: Locally Advanced or Metastatic Breast Cancer

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial