Brief Title
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
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.
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Analysis of the association of molecular anomalies on cDNA with clinical histological data.
Condition
Circulating Tumor DNA
Intervention
One arm only
Study Arms / Comparison Groups
One arm only
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
40
Start Date
June 19, 2020
Completion Date
December 19, 2021
Primary Completion Date
June 19, 2021
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Camille Mrs EVRARD, PHD, +33549444279, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04456972
Organization ID
ENDOCIRC
Responsible Party
Sponsor
Study Sponsor
Poitiers University Hospital
Study Sponsor
Camille Mrs EVRARD, PHD, Principal Investigator, CHU Poitiers
Verification Date
June 2020