Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

NCT ID: NCT04456972

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-19

Study Completion Date

2022-01-08

Brief Summary

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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

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Conditions

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Circulating Tumor DNA Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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One arm only

Group Type EXPERIMENTAL

One arm only

Intervention Type DIAGNOSTIC_TEST

Samples of plasma to analyze ctDNA

Interventions

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One arm only

Samples of plasma to analyze ctDNA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille Mrs EVRARD, PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

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CHU Poitiers, PRC

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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ENDOCIRC

Identifier Type: -

Identifier Source: org_study_id

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