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

Not Applicable

Recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT06603506
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Study Start: 2024-11-21
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2027-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of establishment of exploitable tumor organoid lines	through study completion, an average of 3 years	Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France