NCT03766672

Brief Summary

In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type 2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although targeted therapies are used in many types of cancer, they are still possible a minority of patients. In current practice, endometrial cancers do not benefit these therapies. Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial carcinoma could help to identify biomarkers predictive of a response to targeted therapies. We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

November 30, 2018

Last Update Submit

August 20, 2024

Conditions

Keywords

Endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of biomarkers identified by Next Generation Sequencing involved in type 2 endometrial tumors in Martinique

    Characterization of potentially operable mutations in type 2 endometrial tumors from DNA sample withdraw at inclusion and during follow visit

    24 Months

Study Arms (1)

Intervention Arm

Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA .

Diagnostic Test: Intervention Arm

Interventions

Intervention ArmDIAGNOSTIC_TEST

The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.

Intervention Arm

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged more 18 years living in Martinique with a type 2 endometrial cancer confrimed by with anatomopathological reports.

You may qualify if:

  • Major subject living in Martinique with the following characteristics :
  • Patients with type 2 endometrial cancer, with anatomopathological confirmation
  • Affiliate or beneficiary of french social security.

You may not qualify if:

  • Type 1 adenocarcinoma
  • Patients not affiliated to french social security
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Martinique

Fort-de-France, Martinique

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples for extraction of DNA on whole blood

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Medhi JEAN-LAURENT, MD

    CHU Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 6, 2018

Study Start

November 22, 2019

Primary Completion

November 22, 2021

Study Completion

July 22, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations