Circulating Tumor DNA Study in Patients With Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Other: Whole blood
- Registration Number
- NCT05955079
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 130
- 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
- Failure to sign the OncoCentre consent form
- Refusal of OncoCentre consent
- Patient not eligible for upfront curative surgical treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endometrial Cancer Whole blood Patients over 18 years old with a biopsy-proven endometrial cancer, at FIGO stage I to IV, and amenable and undergoing surgical treatment
- Primary Outcome Measures
Name Time Method Recurrence-free survival 1 year
- Secondary Outcome Measures
Name Time Method Frequency of ctDNA detection based on established prognostic parameters 3 years 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).
Frequency of ctDNA detection based on the recurrence profile 3 years 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))
Frequency of ctDNA detection in other prognostic groups 3 years Frequency of ctDNA detection in other prognostic groups according to the 2021 ESGO-ESTRO-ESP classification
Recurrence-free survival 3 years
Trial Locations
- Locations (1)
H么pital Cochin
馃嚝馃嚪Paris, France