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)

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 - a Prospective, Multi-centre Human Research Ordinance Research Project / Category A

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Cancer; Adenocarcinoma of Ovary; Adenocarcinoma, Tubular

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland
  • Zürich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced and metastatic High-Grade Adenocarcinoma (HGAC) of ovarian, tubal or peritoneal origin

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sample Processing and Report Generation (1)	- Number of samples with sufficient material and quality for intended analysis.	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.	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.	Through study completion, an average of 1 year
Sample Processing and Report Generation (4)	- Number of molecular summary reports available for the Tumour Board.	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.	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.	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.	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.	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	Through study completion, an average of 1 year
Time to first subsequent treatment (TTFST)	Time to first subsequent treatment (TTFST), incl. best supportive care	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])	Through study completion, at least 6 month of follow up
Terminations due to toxicity	Frequency (proportion) of patients terminating treatment due to toxicity	Through study completion, at least 6 month of follow up
Survival	Overall survival (OS), calculated from registration until death due to any cause	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	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)	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.	Every 12 weeks (+/- 2 weeks) for 6 months after last tumour sampling (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Andreas Wicki, Prof. Dr. med., University Hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic Cancer; Advanced Ovarian Cancer; High-Grade Adenocarcinoma; Tubal Origin; Peritoneal Origin; Tumour Profiling
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2018-02052; me18Wicki

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No