University Hospital for Tumours of Zagreb

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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)

[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.

[[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) (KATE3) (University Hospital for Tumors of Zagreb)]]

[2]

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

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 [3].

Contact information: Contact [4].