Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

NCT04456972 | Completed

• 1 other identifier: ENDOCIRC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulating Tumor DNA; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

One arm only

EXPERIMENTAL

Diagnostic Test: One arm only

Interventions

One arm only DIAGNOSTIC_TEST

Samples of plasma to analyze ctDNA

One arm only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers, PRC

Poitiers, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Camille Mrs EVRARD, PHD

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 7, 2020
• Study Start: June 19, 2020
• Primary Completion: January 8, 2022
• Study Completion: January 8, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)