Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

Endometrial Neoplasms Clinical Trial

— ENDO-NGS-MQ  

Official title:

Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766672
• Other study ID #: 18_RIPH2_15
• Secondary ID: 2018-A02091-54
• Status: Active, not recruiting
• Start date: November 22, 2019
• Est. completion date: November 22, 2024

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 22, 2024
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Neoplasms

Intervention

Diagnostic Test:
• Intervention Arm
The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.

Locations

Country	Name	City	State
Martinique	Chu Martinique	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	Martinique Cancer Registry

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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