Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456972
• Other study ID #: ENDOCIRC
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: January 8, 2022

Study information

• Verified date: January 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 8, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Diagnostic Test:
• One arm only
Samples of plasma to analyze ctDNA

Locations

Country	Name	City	State
France	CHU Poitiers, PRC	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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