Clinical trial NCT05955079: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
Digital-PCR
Circulating Tumor DNA
minimal residual disease
liquid biopsy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: CARPEM, Institut du Cancer Paris
name: Centre de recherche des Cordeliers
name: METHYS DX
First posted: 2023-07-21
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing clinically-indicated hysterectomy for endometrial cancer at the University Paris Cité hospital Cochin, who are age 18 years and older

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 criteria: 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

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 3 years
measure: Frequency of ctDNA detection based on established prognostic parameters
timeFrame: 3 years
measure: Frequency of ctDNA detection in other prognostic groups
timeFrame: 3 years
measure: Frequency of ctDNA detection based on the recurrence profile
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bruno BORGHESE, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérôme ALEXANDRE, MD, PhD
role: STUDY_CHAIR
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