Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Poitiers University Hospital
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- 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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
One arm only
Intervention: One arm only (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Time Frame: 15 days
Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
Secondary Outcomes
- Analysis of the association of molecular anomalies on cDNA with clinical histological data.(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.(3 months)