Back to resultsReliability and Interest of Circulating Tumor DNA in Endometrial Cancers.
Primary Purpose
Circulating Tumor DNA, Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
One arm only
Sponsored by
About this trial
This is an interventional diagnostic trial for Circulating Tumor DNA
Eligibility Criteria
Inclusion Criteria:
- Histologically proven endometrial adenocarcinoma type I or type II.
- With recent abdomino-pelvic imaging, less than 3 months old.
- Tumor tissue sufficiently exploitable for research (> 20% of tumor cells)
- Informed consent signed by the patient after clear and fair information about the study.
- Free patient, without tutorship, curatorship or subordination.
- Patient benefiting from a Social Security scheme or benefiting from it through a third person.
- Patient not opposed to participating in the study.
Exclusion Criteria:
- Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
- Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
- Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
- Pregnant and / or lactating women
Sites / Locations
- CHU Poitiers, PRC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One arm only
Arm Description
Outcomes
Primary Outcome Measures
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
Secondary Outcome Measures
Analysis of the association of molecular anomalies on cDNA with clinical histological data.
Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.
Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.
Full Information
NCT ID
NCT04456972
First Posted
June 15, 2020
Last Updated
January 2, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04456972
Brief Title
Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.
Official Title
Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
January 8, 2022 (Actual)
Study Completion Date
January 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.
After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).
This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor DNA, Endometrial Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One arm only
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
One arm only
Intervention Description
Samples of plasma to analyze ctDNA
Primary Outcome Measure Information:
Title
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
Description
Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Analysis of the association of molecular anomalies on cDNA with clinical histological data.
Description
Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
Time Frame
15 days
Title
Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.
Description
Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven endometrial adenocarcinoma type I or type II.
With recent abdomino-pelvic imaging, less than 3 months old.
Tumor tissue sufficiently exploitable for research (> 20% of tumor cells)
Informed consent signed by the patient after clear and fair information about the study.
Free patient, without tutorship, curatorship or subordination.
Patient benefiting from a Social Security scheme or benefiting from it through a third person.
Patient not opposed to participating in the study.
Exclusion Criteria:
Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
Pregnant and / or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Mrs EVRARD, PHD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Poitiers, PRC
City
Poitiers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.
If we failed to obtain results we perhaps send plasma in other laboratory
Learn more about this trial
Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.
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