Circulating Tumor DNA Study in Patients With Endometrial Cancer (ctDNA-endo)

July 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometrial Cancer
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
3 samples (before, after surgery and before chemotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 3 years
3 years
Frequency of ctDNA detection based on established prognostic parameters
Time Frame: 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).
3 years
Frequency of ctDNA detection in other prognostic groups
Time Frame: 3 years
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
Time Frame: 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))
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

CARPEM, Institut du Cancer Paris
Centre de recherche des Cordeliers
METHYS DX

Investigators

  • Study Director: Bruno BORGHESE, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Study Chair: Jérôme ALEXANDRE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC22003
  • 20200812151455 (Other Identifier: AP-HP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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