NCT06603506

Brief Summary

This study comprises 3 stages:

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2024Oct 2027

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

September 6, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

endometrial cancerorganoidePARP inhibitor

Outcome Measures

Primary Outcomes (1)

  • Rate of establishment of exploitable tumor organoid lines

    Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.

    through study completion, an average of 3 years

Study Arms (1)

tumour and blood collection

tumour and blood collection for realization ex vivo organoid models

Other: tumour and blood samples

Interventions

Tumour and blood samples

tumour and blood collection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with localized endometrial cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, France

RECRUITING

Related Publications (1)

  • 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 organoids from endometrial cancer to assess efficacy of PARP inhibitors. BMC Cancer. 2025 Feb 11;25(1):244. doi: 10.1186/s12885-025-13590-6.

Biospecimen

Retention: SAMPLES WITH DNA

blood and tissue

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Gwenn LE GALL, Medical Doctor

CONTACT

François CHERIFI, Medical Doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

November 21, 2024

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations