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)

NCT06599749 | Completed

• 1 other identifier: 2018-02052; me18Wicki
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Adenocarcinoma of Ovary; Adenocarcinoma, Tubular; Peritoneal Cancer

Keywords

Advanced Ovarian Cancer; High-Grade Adenocarcinoma; Tubal Origin; Peritoneal Origin; Metastatic Cancer; Tumour Profiling

Outcome Measures

Primary Outcomes (16)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

University Hospital Basel

Basel, 4031, Switzerland

Location

Kantonsspital Baselland

Liestal, 4410, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: NONE RETAINED

Tumor tissue, blood and, if applicable, ascites fluid sample

MeSH Terms

Conditions

Adenocarcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Wicki, Prof. Dr. med.

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CH (3)