Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study (PENDOR)

November 25, 2024 updated by: Centre Francois Baclesse

This study comprises 3 stages:

  1. Collection of tumor and blood samples.
  2. Creation of organoid models based on tumor samples.
  3. Development of functional tests to predict clinical response to treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with localized endometrial cancer

Description

Inclusion Criteria:

  • Patient aged 18 years or more
  • Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.

  • Patient with localized endometrial cancer, presenting:

    • A high-grade endometrioid histological type and/or
    • P53 mutation and/or
    • a non-endometrioid histological type regardless of P53 status.
  • Patient affiliated to a social security scheme
  • Information and signature of informed consent prior to any specific study procedure

Exclusion Criteria:

  • Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).
  • Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tumour and blood collection
tumour and blood collection for realization ex vivo organoid models
Other: tumour and blood samples
Tumour and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of establishment of exploitable tumor organoid lines
Time Frame: through study completion, an average of 3 years
Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01206-41 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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