Adenocarcinoma of Ovary, Adenocarcinoma, Tubular, Peritoneal Cancer
Conditions
Keywords
Advanced Ovarian Cancer, High-Grade Adenocarcinoma, Tubal Origin, Peritoneal Origin, Metastatic Cancer, Tumour Profiling
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Eastern Cooperative Oncology Group performance status score ≤ 2 (not bedridden for more than 50% of waking hours) * Primary or recurrent HGAC of ovarian, tubal or peritoneal origin International Federation of Gynecology and Obstetrics (FIGO) stage III or IV * Written informed consent according to national legal and regulatory requirements prior to any project specific procedures
Exclusion criteria
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the project leader may interfere with the project or affect patient compliance * Legal incompetence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sample Processing and Report Generation (1) | Through study completion, an average of 1 year | \- Number of samples with sufficient material and quality for intended analysis. |
| Sample Processing and Report Generation (2) | Through study completion, an average of 1 year | \- Number of successfully processed samples per technology, with quality checks passed and interpretable results generated. |
| Sample Processing and Report Generation (3) | Through study completion, an average of 1 year | \- Successful data transfers into the research data management system, ensuring results are timely for inclusion in the molecular research report. |
| Sample Processing and Report Generation (4) | Through study completion, an average of 1 year | \- Number of molecular summary reports available for the Tumour Board. |
| Sample Processing and Report Generation (5) | Through study completion, an average of 1 year | \- Proportion of cases where the Tumour Board found the molecular report useful for treatment recommendations. |
| Sample Processing and Report Generation (6) | Through study completion, an average of 1 year | \- Proportion of cases where the treating physician found the Tumour Board's recommendation useful for treatment decisions. |
| Sample Processing and Report Generation (7) | Through study completion, an average of 1 year | \- Types and combinations of molecular information considered useful for treatment recommendations beyond routine diagnostics. |
| Classification of Proposed Treatment Options | Through study completion, an average of 1 year | 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. |
| Classification of Tumour Board Recommendations | Through study completion, an average of 1 year | 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 to first subsequent treatment (TTFST) | Through study completion, at least 6 month of follow up | Time to first subsequent treatment (TTFST), incl. best supportive care |
| Time to first subsequent treatment (TTFST) ratio | Through study completion, at least 6 month of follow up | Time to first subsequent treatment (TTFST) ratio (TTFST 2 / TTFST 1: TTFST 2 = TTFST on current project; TTFST 1 = TTFST on previous treatment \[before entering the project\]) |
| Terminations due to toxicity | Through study completion, at least 6 month of follow up | Frequency (proportion) of patients terminating treatment due to toxicity |
| Survival | Through study completion, at least 6 month of follow up | Overall survival (OS), calculated from registration until death due to any cause |
| Event free survival (EFS) | Through study completion, at least 6 month of follow up | Event free survival (EFS), defined as time to treatment failure or death |
| Radiological tumour response | Through study completion, at least 6 month of follow up | 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) |
| Quality of Life (FAC-G7) questionnaire | Every 12 weeks (+/- 2 weeks) for 6 months after last tumour sampling (day 0) | 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. |
Countries
Switzerland
Outcome results
None listed