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Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04456972
Enrollment
44
Registered
2020-07-07
Start date
2020-06-19
Completion date
2022-01-08
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor DNA, Endometrial Cancer

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.

Interventions

DIAGNOSTIC_TESTOne arm only

Samples of plasma to analyze ctDNA

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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.15 daysConcordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment

Secondary

MeasureTime frameDescription
Analysis of the association of molecular anomalies on cDNA with clinical histological data.15 daysAssociation of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
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 monthsAssociation of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026