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Recruiting NCT06603506

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

Observational Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tumour and blood samples.
Who it may be relevant to
Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other tumour and blood samples
    Tumour and blood samples

Primary outcome measures

  • Rate of establishment of exploitable tumor organoid lines [Time frame: through study completion, an average of 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre François Baclesse — Caen

Publications

  • Gall GL, Cherifi F, Divoux J, Florent R, Christy F, Leconte A, San C, Devillers A, Desmartin G, Lecouflet L, Clarisse B, Ballesta S, Thorel L, Dubois B, Harter V, Rousseau N, Gaichies L, Martin-Francoise S, Le Brun JF, Dolivet E, Rouzier R, Jeanne C, Blanc-Fournier C, Figeac M, Leman R, Castera L, Poulain L, Weiswald LB, Joly F. The PENDOR study: establishment of a panel of patient-derived tumor o PMID 39934735

Identifiers

NCT: NCT06603506 · 2024-A01206-41 · 2024-A01206-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗