Endometrial NeoplasmsENDO-NGS-MQNCT03766672
Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique
An observational study of Endometrial Neoplasms, run by University Hospital Center of Martinique at 1 site in Martinique.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Intervention Arm
- How many people
- 30 participants
- Where
- 1 siteMartinique
- Study dates
- 22 Nov 2019to 22 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women aged more 18 years living in Martinique with a type 2 endometrial cancer confrimed by with anatomopathological reports.
Who may be able to join
- 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).
Who cannot join
- Type 1 adenocarcinoma
- Patients not affiliated to french social security
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Endometrial Neoplasms
- Being tested
- Intervention Arm
- Keywords
- Endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmDiagnostic test
The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA . Receives: Diagnostic Test: Intervention Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start22 Nov 2019
- Primary completion22 Nov 2021
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Martinique Cancer Registry
- Responsible party
- Sponsor
- Investigators
- Medhi JEAN-LAURENT, MD, Principal investigator, CHU Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766672
- Sponsor's protocol ID
- 18_RIPH2_15
- Other IDs
- 2018-A02091-54
- Acronym
- ENDO-NGS-MQ
- Status last verified
- Aug 2024
- First submitted
- 30 Nov 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique
- ClinicalTrials.gov ID
- NCT03766672
- Acronym / sponsor ID
- ENDO-NGS-MQ / 18_RIPH2_15
- Conditions
- Endometrial Neoplasms
- Keywords
- Endometrial carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Martinique Cancer Registry
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | – | Diagnostic Test: Intervention ArmIdentify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA . |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women aged more 18 years living in Martinique with a type 2 endometrial cancer confrimed by with anatomopathological reports.
Key inclusion criteria (4 listed)
- Major subject living in Martinique with the following characteristics :
Key exclusion criteria (3 listed)
- Type 1 adenocarcinoma
- Patients not affiliated to french social security
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ArmThe intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique. | Diagnostic test | Intervention Arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medhi JEAN-LAURENT, MD principal investigator
CHU Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biomarkers identified by Next Generation Sequencing involved in type 2 endometrial tumors in Martinique (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.