The aim of this prospective, multi-centre, exploratory research project is the establishment of a platform for in-depth tumour profiling in patients with advanced and metastatic High-Grade Adenocarcinoma (HGAC) of ovarian, tubal or peritoneal origin.
TUPRO-Gyn is part of the Tumour Profiler (TUPRO) research collaboration, which aims to help generate information about patients' individual tumour biology for patients with advanced malignancies, using innovative biotechnologies and computational analyses for in-depth molecular profiling. The TUPRO-Gyn study focuses on improving treatment for patients with advanced ovarian, tubal, or peritoneal cancer, who often face poor outcomes and limited options after initial therapy. The study aims to use advanced molecular profiling technologies to identify specific characteristics of tumors that can be targeted with personalized treatments. By building a comprehensive platform for in-depth tumor analysis, the project hopes to discover new biomarkers and support future clinical trials that match treatments to the molecular profile of individual tumors, potentially leading to better patient outcomes.
Study Type
OBSERVATIONAL
Enrollment
80
University Hospital Basel
Basel, Switzerland
Kantonsspital Baselland
Liestal, Switzerland
University Hospital Zurich
Zurich, Switzerland
Sample Processing and Report Generation (1)
\- Number of samples with sufficient material and quality for intended analysis.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (2)
\- Number of successfully processed samples per technology, with quality checks passed and interpretable results generated.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (3)
\- Successful data transfers into the research data management system, ensuring results are timely for inclusion in the molecular research report.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (4)
\- Number of molecular summary reports available for the Tumour Board.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (5)
\- Proportion of cases where the Tumour Board found the molecular report useful for treatment recommendations.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (6)
\- Proportion of cases where the treating physician found the Tumour Board's recommendation useful for treatment decisions.
Time frame: Through study completion, an average of 1 year
Sample Processing and Report Generation (7)
\- Types and combinations of molecular information considered useful for treatment recommendations beyond routine diagnostics.
Time frame: Through study completion, an average of 1 year
Classification of Proposed Treatment Options
Possible treatment options are classified as follows: * On-label molecularly matched treatment or immunotherapy (per SwissMedic), with or without radiotherapy/chemotherapy; * Classical chemotherapy, with or without radiotherapy (on-label if applicable); * Referral to a clinical trial; * Off-label molecularly matched treatment or immunotherapy (per SwissMedic), with or without radiotherapy/chemotherapy; * Off-label treatment authorized in countries with comparable standards to SwissMedic, with or without radiotherapy/chemotherapy; * Best supportive care (no active anti-tumor treatment). Treatment options are discussed in an interdisciplinary Tumour Board, considering patient-centered factors like previous treatments, disease history, clinical status, and patient preferences.
Time frame: Through study completion, an average of 1 year
Classification of Tumour Board Recommendations
Grading of treatment recommendations using the European Society for Medical Oncology Scale for Clinical Actionability of Molecular Targets (ESCAT): I-A: Randomized trials show survival improvement with a tumor's alteration-drug match. I-B: Non-randomized trials show benefits in a specific tumor type. I-C: Clinical benefit seen across various tumor types or in basket trials. II-A: Retrospective studies show benefit in patients with a specific alteration vs. those without. II-B: Trials show better drug responsiveness, but no survival data. III-A: Benefit shown in a different tumor type; limited evidence for the patient's cancer type. III-B: Predicted impact similar to a studied alteration, lacking data. IV-A: Pre-clinical models show alteration affects drug sensitivity. IV-B: Actionability predicted in silico. V: Targeted therapy shows responses but no improved outcomes. X: No evidence the alteration is actionable
Time frame: Through study completion, an average of 1 year
Time to first subsequent treatment (TTFST)
Time to first subsequent treatment (TTFST), incl. best supportive care
Time frame: Through study completion, at least 6 month of follow up
Time to first subsequent treatment (TTFST) ratio
Time to first subsequent treatment (TTFST) ratio (TTFST 2 / TTFST 1: TTFST 2 = TTFST on current project; TTFST 1 = TTFST on previous treatment \[before entering the project\])
Time frame: Through study completion, at least 6 month of follow up
Terminations due to toxicity
Frequency (proportion) of patients terminating treatment due to toxicity
Time frame: Through study completion, at least 6 month of follow up
Survival
Overall survival (OS), calculated from registration until death due to any cause
Time frame: Through study completion, at least 6 month of follow up
Event free survival (EFS)
Event free survival (EFS), defined as time to treatment failure or death
Time frame: Through study completion, at least 6 month of follow up
Radiological tumour response
Proportion of patients with a radiological tumour response (complete response (CR) / partial response (PR)) according to local standards and trial protocol (in case of referral or trial)
Time frame: Through study completion, at least 6 month of follow up
Quality of Life (FAC-G7) questionnaire
Quality of Life assessed using the Functional Assessment of Cancer Therapy - General 7 (FACT-G7) questionnaire. The FACT-G7 uses a Likert scale, where responses range from 0 (not at all) to 4 (very much). Higher scores indicate better quality of life, while lower scores suggest more severe symptoms or a poorer quality of life.
Time frame: Every 12 weeks (+/- 2 weeks) for 6 months after last tumour sampling (day 0)
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