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Trial Title:
Circulating Tumor DNA Study in Patients With Endometrial Cancer
NCT ID:
NCT05955079
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Endometrial Cancer
Digital-PCR
Circulating Tumor DNA
minimal residual disease
liquid biopsy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Whole blood
Description:
3 samples (before, after surgery and before chemotherapy)
Arm group label:
Endometrial Cancer
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.
Criteria for eligibility:
Study pop:
Women undergoing clinically-indicated hysterectomy for endometrial cancer at the
University Paris Cité hospital Cochin, who are age 18 years and older
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
BEINSE Guillaume, MD, PhD
Phone:
+33 1 58 41 14 54
Email:
guillaume.beinse@aphp.fr
Contact backup:
Last name:
GAUDET CHARDONNET Antoine, MD
Phone:
+33 1 58 41 36 61
Email:
antoine.gaudetchardonnet@aphp.fr
Start date:
January 1, 2021
Completion date:
January 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
CARPEM, Institut du Cancer Paris
Agency class:
Other
Collaborator:
Agency:
Centre de recherche des Cordeliers
Agency class:
Other
Collaborator:
Agency:
METHYS DX
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05955079
https://carpem.fr/activites/les-plateformes/biobanques/projets-de-recherche-collection-oncocentre/
