Clinical trial NCT06599749: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma of Ovary
Adenocarcinoma, Tubular
Peritoneal Cancer
Keywords: Advanced Ovarian Cancer
High-Grade Adenocarcinoma
Tubal Origin
Peritoneal Origin
Metastatic Cancer
Tumour Profiling
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced and metastatic High-Grade Adenocarcinoma (HGAC) of ovarian, tubal or peritoneal origin

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sample Processing and Report Generation (1)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (2)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (3)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (4)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (5)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (6)
timeFrame: Through study completion, an average of 1 year
measure: Sample Processing and Report Generation (7)
timeFrame: Through study completion, an average of 1 year
measure: Classification of Proposed Treatment Options
timeFrame: Through study completion, an average of 1 year
measure: Classification of Tumour Board Recommendations
timeFrame: Through study completion, an average of 1 year
measure: Time to first subsequent treatment (TTFST)
timeFrame: Through study completion, at least 6 month of follow up
measure: Time to first subsequent treatment (TTFST) ratio
timeFrame: Through study completion, at least 6 month of follow up
measure: Terminations due to toxicity
timeFrame: Through study completion, at least 6 month of follow up
measure: Survival
timeFrame: Through study completion, at least 6 month of follow up
measure: Event free survival (EFS)
timeFrame: Through study completion, at least 6 month of follow up
measure: Radiological tumour response
timeFrame: Through study completion, at least 6 month of follow up
measure: Quality of Life (FAC-G7) questionnaire
timeFrame: Every 12 weeks (+/- 2 weeks) for 6 months after last tumour sampling (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital, Zürich
name: Andreas Wicki, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: