Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

Study Overview
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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.

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

Conditions
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Circulating Tumor DNA, Endometrial Cancer

Intervention / Treatment
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* Diagnostic Test: One arm only


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm only<br> | Diagnostic Test: One arm only<br>* Samples of plasma to analyze ctDNA<br>|

What is the study measuring?
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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 |