Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique (ENDO-NGS-MQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766672
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
Martinique Cancer Registry
Information provided by (Responsible Party):
University Hospital Center of Martinique

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Endometrial Neoplasms Diagnostic Test: Intervention Arm

Detailed Description:
Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of metastatic recurrence and death even when diagnosed at early stages. They also have few therapeutic options. The Characterize the mutations responsible of cancer development has led to develope "precision medicine" that targets "actionable genes" by a drug. This concept of actionable mutation refers to a change in the DNA molecule that can predict the response to a drug defined as targeted therapy. Although targeted therapies are used in many types of cancer, they still target a minority of patients. Some tumor sites still do not benefit from these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few therapeutic options. The characterization of molecular mechanisms, by Next Generation Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2 cancers, should allow the identification of predictive biomarkers for response to certain targeted therapies.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique
Actual Study Start Date : November 22, 2019
Actual Primary Completion Date : November 22, 2021
Estimated Study Completion Date : November 22, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of biomarkers identified by Next Generation Sequencing involved in type 2 endometrial tumors in Martinique [ Time Frame: 24 Months ]
    Characterization of potentially operable mutations in type 2 endometrial tumors from DNA sample withdraw at inclusion and during follow visit


Biospecimen Retention:   Samples With DNA
Samples for extraction of DNA on whole blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged more 18 years living in Martinique with a type 2 endometrial cancer confrimed by with anatomopathological reports.
Criteria

Inclusion Criteria:

  • 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.
    • Free, informed with a written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any research required by the research).

Exclusion Criteria:

  • Type 1 adenocarcinoma
  • Patients not affiliated to french social security
  • Refusal to participate.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766672


Locations
Layout table for location information
Martinique
Chu Martinique
Fort-de-France, Martinique
Sponsors and Collaborators
University Hospital Center of Martinique
Martinique Cancer Registry
Investigators
Layout table for investigator information
Principal Investigator: Medhi JEAN-LAURENT, MD CHU Martinique
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03766672    
Other Study ID Numbers: 18_RIPH2_15
2018-A02091-54 ( Other Identifier: ANSM )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
Endometrial carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases