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Circulating Tumor DNA Study in Patients With Endometrial Cancer — ctDNA-endo  

Endometrial Cancer Clinical Trial

Official title:
Prospective Validation of the Association Between Circulating Tumor DNA Detection and Risk of Metastatic Relapse in Patients With Localized Endometrial Cancer

Clinical Trial Summary

The objective of this study is to identify a population at risk of early recurrence after oncologic resection surgery of a primary uterine tumor based on the detection of ctDNA

Clinical Trial Description

Despite early management, the risk of recurrence in non-metastatic endometrial cancer (FIGO I-III) is approximately 10-20%. The challenge is to identify the most high-risk cases for relapse in order to adapt surgical and medical management. The development of digital PCR methods in nano-droplets, detecting circulating tumor DNA (ctDNA) with high sensitivity, could help to better specify the prognosis of patients with localized endometrial cancer and to identify a population with residual disease, the source of this ctDNA. The investigators established a universal methylation signature in the laboratory based on analysis of endometrial cancer-specific DNA methylation using in silico analysis of public data from the Cancer Genome Atlas, validated in an independent cohort, with 99% sensitivity and 98% specificity. A prospective biological cohort was established between the gynecology and medical oncology departments and the Cochin Hospital biological resources center (CARPEM-OncoCentre collection). This is a prospective monocentric biological collection study. The aim of this study is to evaluate the prognostic impact of pre- and post-operative ctDNA detection in stage I-III endometrial cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05955079
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Guillaume BEINSE, MD, PhD
Phone +33 1 58 41 14 54
Email guillaume.beinse@aphp.fr
Status Recruiting
Phase
Start date January 1, 2021
Completion date January 2026
View Details
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