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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Other: Whole blood

Study type: Observational

Funder types: Other

Identifiers

NCT05955079

20200812151455 (Other Identifier)

CRC22003

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients over 18 years of age who are potentially eligible for inclusion in the OncoCentre collection (registered as a patient at APHP, without legal protection measures, affiliated with a social security system)
• Patients diagnosed with histologically documented endometrial cancer on an endometrial biopsy
• Surgical intervention performed at Hopital Cochin

Exclusion criteria

• Failure to sign the OncoCentre consent form
• Refusal of OncoCentre consent
• Patient not eligible for upfront curative surgical treatment

Trial design

130 participants in 1 patient group

Endometrial Cancer

Description:

Patients over 18 years old with a biopsy-proven endometrial cancer, at FIGO stage I to IV, and amenable and undergoing surgical treatment

Treatment:

Other: Whole blood