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Completed

NCT Number: NCT03766672

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Arm

Diagnostic Test

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Collaborators

  • Martinique Cancer Registry

Registry information

Acronym: ENDO-NGS-MQ

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Dec 6, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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