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'''[https://clinicaltrials.gov/ct2/show/NCT03782207?recrs=abdfm&cond=Cancer&locn=Clinical+Hospital+Center+Sestre+Milosrdnice%3B+Clinic+for+tumors&cntry=HR&draw=2&rank=2 | '''[[ A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice (IMreal) (University Hospital for Tumors of Zagreb) ]]''' | ||
[https://clinicaltrials.gov/ct2/show/NCT03782207?recrs=abdfm&cond=Cancer&locn=Clinical+Hospital+Center+Sestre+Milosrdnice%3B+Clinic+for+tumors&cntry=HR&draw=2&rank=2] | |||
'''Summary:''' This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice. | '''Summary:''' This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice. | ||
Revision as of 15:56, 30 October 2023
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Trials
A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice (IMreal) (University Hospital for Tumors of Zagreb) [1]
Summary: This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.
Sponsor, manager, or home institution: Hoffmann-La Roche
Intervention/Treatment: Drug: Atezolizumab
Number of patients: 3400 participants
Beginning Date: December 20, 2018
Last Update: December 20, 2022
Recruitment Status: Recruiting.
Cancer areas of interest: Urothelial Carcinoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma
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, manager, or home institution: Hoffmann-La Roche
Intervention/Treatment: Drug: Trastuzumab Emtansine; Drug: Atezolizumab; Other: Placebo
Number of patients: 320 participants
Beginning Date: February 5, 2021
Last Update: December 14, 2022
Recruitment Status: Recruiting
Cancer areas of interest: Metastatic Breast Cancer
Experts
Department of Anesthesiology, Reanimatology and Intensive Treatment
Department of Head and Neck Surgery
Department of Gynecological-Oncological Surgery
Department of Oncological Pathology and Clinical Cytology
Department of Internal Oncology
Department of Radiotherapy and Oncology
Learning Resources
Resource: Library of the University Hospital for Tumors
Content Type: Library containing publications from the field of oncology and other biomedical subjects such as surgery, radiology, anesthesia, otorhinolaryngology, internal medicine, radiotherapy, etc. The library can also be used to search medical databases, bibliometric services and certificates, and other information. Librarians can help with instructions on how to find relevant literature. There are currently about 1,722 printed books and about 14,000 volumes of magazines (130 titles).
Target Audience: Anyone in the region can access the library and create an account. The content is more relevant to providers and researchers.
Data Access: Library can be accessed here.
Novel Therapies and Diagnostic Methods
Diagnostics
| Radiology | |||
|---|---|---|---|
| Type | Name | Availability | Uses per year |
| Machine | CT scanners | Yes | |
| Machine | Facilities for MRI (specify the strength and field of the techniques) | Yes | |
| Machine | Mammography (please specify analogic mammography or digital) | Yes | |
| Machine | Ultrasound | Yes | |
| Technique | CT guided biopsis | Yes | |
| Technique | E/S Fine-needle biopsy | Yes | |
| Technique | Vacuum-assisted breast biopsy (VABB) | Yes | |
| Technique | Angiography | Yes | |
| Nuclear Medicine | |||
| Type | Name | Availability | Uses per year |
| Machine | PET Scan | Yes | |
| Machine | PET CT | Yes | |
| Machine | SPECT CT | Yes | |
| Technique | Bone scintigraphy | Yes | |
| Pathology | |||
| Type | Name | Availability | Uses per year |
| Facility | Cytology laboratory | Yes | |
| Pathology: Molecular Tests | |||
| Type | Name | Availability | Uses per year |
| Technique | KRAS | Yes | |
| Technique | EGFR | Yes | |
| Technique | HER2 status | Yes | |
| !! !! !! |
Treatment
| Surgical Oncology | |||
|---|---|---|---|
| Type | Name | Availability | Uses per year |
| Specialist | Gynaecological surgery | Yes | |
| Machine | Ultrasonic Scapel | Yes | |
| Radiotherapy | |||
| Type | Name | Availability | Uses per year |
| Machine | Linear accelerators | Yes | |
| Machine | Linear accelerators with IMRT/VMAT | Yes | |
| Machine | Respirator | Yes | |
| Machine | Gamma Knife | Yes | |
| Hemato-Oncology / Bone Marrow Transplants | |||
| Type | Name | Availability | Uses per year |
| Facility | Transfusion Unit | Yes |
EHDEN Participation
The Clinical Hospital Center “Sestre Milosrdnice” is part of the EHDEN Network of Data Partners.
The European Health Data and Evidence Network (EHDEN) aims to standardize European health data using OMOP-CDM to facilitate research. The project creates a federated network of data sources for easy access by researchers and policymakers. Its goal is to improve healthcare outcomes through better data quality and interoperability.
Primary purpose: To serve as an all-encompassing platform that manages various hospital processes from admission to discharge, with ongoing updates for medical, administrative, and legislative changes.
Type of information: The database contains patient-centric data covering a wide range of hospital activities, from appointments and diagnostics to nursing and transfers, structured up to CDA level 2 details.
Data level: Regional level.
Number of records: 600,000 patients.
Data range: 2010.
Open Data Access: Data is not publicly available. Instructions for data request [2].
Contact information: Contact [3].