Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Advanced and Metastatic High-Grade Adenocarcinoma of Ovarian, Tubal or Peritoneal Origin (TUPRO-Gyn)

Primary outcomes

1. Sample Processing and Report Generation (1)

   Time frame: Through study completion, an average of 1 year

   • Number of samples with sufficient material and quality for intended analysis.

2. Sample Processing and Report Generation (2)

   Time frame: Through study completion, an average of 1 year

   • Number of successfully processed samples per technology, with quality checks passed and interpretable results generated.

3. Sample Processing and Report Generation (3)

   Time frame: 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.

4. Sample Processing and Report Generation (4)

   Time frame: Through study completion, an average of 1 year

   • Number of molecular summary reports available for the Tumour Board.

5. Sample Processing and Report Generation (5)

   Time frame: Through study completion, an average of 1 year

   • Proportion of cases where the Tumour Board found the molecular report useful for treatment recommendations.

6. Sample Processing and Report Generation (6)

   Time frame: 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.

7. Sample Processing and Report Generation (7)

   Time frame: Through study completion, an average of 1 year

   • Types and combinations of molecular information considered useful for treatment recommendations beyond routine diagnostics.

8. Classification of Proposed Treatment Options

   Time frame: 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.

9. Classification of Tumour Board Recommendations

   Time frame: 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

10. Time to first subsequent treatment (TTFST)

    Time frame: Through study completion, at least 6 month of follow up

    Time to first subsequent treatment (TTFST), incl. best supportive care

11. Time to first subsequent treatment (TTFST) ratio

    Time frame: 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])

12. Terminations due to toxicity

    Time frame: Through study completion, at least 6 month of follow up

    Frequency (proportion) of patients terminating treatment due to toxicity

13. Survival

    Time frame: Through study completion, at least 6 month of follow up

    Overall survival (OS), calculated from registration until death due to any cause

14. Event free survival (EFS)

    Time frame: Through study completion, at least 6 month of follow up

    Event free survival (EFS), defined as time to treatment failure or death

15. Radiological tumour response

    Time frame: 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)

16. Quality of Life (FAC-G7) questionnaire

    Time frame: 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.