Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

Not Applicable

Completed

• Conditions: Endometrial Cancer; Circulating Tumor DNA
• Interventions: Diagnostic Test: One arm only

• Registration Number: NCT04456972
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.

After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).

This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.

The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study Start: 2020-06-19
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-07
• Primary Completion: 2022-01-08
• Study Completion: 2022-01-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Histologically proven endometrial adenocarcinoma type I or type II.
• With recent abdomino-pelvic imaging, less than 3 months old.
• Tumor tissue sufficiently exploitable for research (> 20% of tumor cells)
• Informed consent signed by the patient after clear and fair information about the study.
• Free patient, without tutorship, curatorship or subordination.
• Patient benefiting from a Social Security scheme or benefiting from it through a third person.
• Patient not opposed to participating in the study.

Exclusion Criteria

• Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
• Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
• Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
• Pregnant and / or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm only	One arm only	-

Primary Outcome Measures

Name	Time	Method
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.	15 days	Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment

Secondary Outcome Measures

Name	Time	Method
Analysis of the association of molecular anomalies on cDNA with clinical histological data.	15 days	Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.	3 months	Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.

Trial Locations

Locations (1)

CHU Poitiers, PRC; 🇫🇷 Poitiers, France