Circulating Tumor DNA Study in Patients With Endometrial Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Other: Whole blood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial Cancer<br>Patients over 18 years old with a biopsy-proven endometrial cancer, at FIGO stage I to IV, and amenable and undergoing surgical treatment | Other: Whole blood<br>* 3 samples (before, after surgery and before chemotherapy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  | 3 years | 
| Frequency of ctDNA detection based on established prognostic parameters | Frequency of ctDNA detection based on established prognostic parameters: histological type (endometrioid, non-endometrioid), grade (low grade, high grade), stage (localized to the uterus stages I-II or stage III with nodal involvement), lymphovascular invasion (present/absent), and molecular group (low risk: POLE, intermediate risk: MSI/NSMP, high risk: TP53). | 3 years | 
| Frequency of ctDNA detection in other prognostic groups | Frequency of ctDNA detection in other prognostic groups according to the 2021 ESGO-ESTRO-ESP classification | 3 years | 
| Frequency of ctDNA detection based on the recurrence profile | Frequency of ctDNA detection based on the recurrence profile : anatomical (locoregional versus distant; abdominal versus extra-abdominal; visceral or nodal) or dynamic (aggressive recurrence (progression-free survival post recurrence <6 months) or non-aggressive (>6 months)) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital-PCR, Circulating Tumor DNA, minimal residual disease, liquid biopsy, Endometrial Cancer