Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer; Circulating Tumor DNA
• Intervention / Treatment: Diagnostic test: One arm only

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille Mrs EVRARD, PHD; Phone Number: +33549444279; Email: camille.evrard@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • CHU Poitiers, PRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One arm only	Diagnostic test: One arm only; Samples of plasma to analyze ctDNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment	15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Camille Mrs EVRARD, PHD, CHU Poitiers

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): January 8, 2022
• Study Completion (Actual): January 8, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: ENDOCIRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.

If we failed to obtain results we perhaps send plasma in other laboratory

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No