Clinical trial NCT04456972: Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.
Official title: Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circulating Tumor DNA
Endometrial Cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 15 days
Secondary outcomes:
measure: Analysis of the association of molecular anomalies on cDNA with clinical histological data.
timeFrame: 15 days
measure: Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.
timeFrame: 3 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers, PRC
Study officials:
affiliation: CHU Poitiers
name: Camille Mrs EVRARD, PHD
role: PRINCIPAL_INVESTIGATOR
References: