Reliability and Interest of Circulating Tumor DNA in Endo... | NCT04456972

Studies
Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

NCT04456972

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jan 4, 2023Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Circulating Tumor DNA
Endometrial Cancer

Interventions

One arm only

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2020Actual

Primary Completion Date

Jan 8, 2022Actual

Completion Date

Jan 8, 2022Actual

First Submitted Date

Jun 15, 2020

First Submission Date that Met QC Criteria

Jun 29, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2023

Last Update Posted Date

Jan 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One arm only	Experimental		Diagnostic Test: One arm only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
One arm only	Diagnostic Test	Samples of plasma to analyze ctDNA	One arm only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	15 days

Secondary Outcomes

Measure	Description	Time Frame
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.	15 days
Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Camille Mrs EVRARD, PHD	CHU Poitiers	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

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