Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, Digital-PCR, Circulating Tumor DNA, minimal residual disease, liquid biopsy
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.
Interventions
OTHERWhole blood
3 samples (before, after surgery and before chemotherapy)
Sponsors
CARPEM, Institut du Cancer Paris
Centre de recherche des Cordeliers
METHYS DX
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 3 years | — |
| 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 in other prognostic groups | 3 years | Frequency of ctDNA detection in other prognostic groups according to the 2021 ESGO-ESTRO-ESP classification |
| 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)) |
Countries
France
Contacts
Primary ContactGuillaume BEINSE, MD, PhD
Backup ContactLaetitia PEAUDECERF
Outcome results
None listed