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Spots Global Cancer Trial Database for Circulating Tumor DNA Study in Patients With Endometrial Cancer

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Trial Identification

Brief Title: Circulating Tumor DNA Study in Patients With Endometrial Cancer

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

Study ID: NCT05955079

Interventions

Whole blood

Study Description

Brief 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

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

H么pital Cochin, Paris, , France

Contact Details

Name: Bruno BORGHESE, MD, PhD

Affiliation: Assistance Publique - H么pitaux de Paris

Role: STUDY_DIRECTOR

Name: J茅r么me ALEXANDRE, MD, PhD

Affiliation: Assistance Publique - H么pitaux de Paris

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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