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Adenocarcinoma of OvaryNCT06599749

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)

An observational study of Adenocarcinoma of Ovary and Adenocarcinoma, Tubular, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
80 participants
Where
3 sitesSwitzerland
Study dates
1 Dec 2018to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • University Hospital Basel

    Basel, 4031

  • Kantonsspital Baselland

    Liestal, 4410

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Keywords
Advanced Ovarian Cancer, High-Grade Adenocarcinoma, Tubal Origin, Peritoneal Origin, Metastatic Cancer, Tumour Profiling
Medical subject headings
Adenocarcinoma, Neoplasm Metastasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sample Processing and Report Generation (1)

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

    Measured: Through study completion, an average of 1 year

  2. Sample Processing and Report Generation (2)

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

    Measured: Through study completion, an average of 1 year

  3. 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.

    Measured: Through study completion, an average of 1 year

  4. Sample Processing and Report Generation (4)

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

    Measured: Through study completion, an average of 1 year

  5. Sample Processing and Report Generation (5)

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

    Measured: Through study completion, an average of 1 year

  6. Sample Processing and Report Generation (6)

    • Proportion of cases where the treating physician found the Tumour Board's recommendation useful for treatment decisions.

    Measured: Through study completion, an average of 1 year

  7. Sample Processing and Report Generation (7)

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

    Measured: Through study completion, an average of 1 year

  8. 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.

    Measured: Through study completion, an average of 1 year

  9. 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

    Measured: Through study completion, an average of 1 year

  10. Time to first subsequent treatment (TTFST)

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

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

  11. 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])

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

  12. Terminations due to toxicity

    Frequency (proportion) of patients terminating treatment due to toxicity

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

  13. Survival

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

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

  14. Event free survival (EFS)

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

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

  15. 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)

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

  16. 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.

    Measured: Every 12 weeks (+/- 2 weeks) for 6 months after last tumour sampling (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Dec 2018
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599749
Sponsor's protocol ID
2018-02052; me18Wicki
Other IDs
2018
Status last verified
Sep 2024
First submitted
23 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adenocarcinoma of Ovary and Adenocarcinoma, Tubular, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sample Processing and Report Generation (1) (time frame: Through study completion, an average of 1 year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06599749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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