Study and Monitoring of Multiple Endocrine Neoplasia Type 1 (NEM)

November 17, 2023 updated by: Centre Hospitalier Universitaire Dijon

Multiple Endocrine Neoplasia Type I (MEN1) is a rare autosomal dominant disorder, predisposing sufferers to the development of endocrine tumors. The three most commont endocrine disorders of MEN1 are the secretory tumours of the parathyroid, pituitary gland and pancreas, in addition to which other tumours may be observed.

The diagnosis of MEN1 is essential for 1) appropriate therapeutic management of proven endocrine disorders, 2) screening for other endocrine and non-endocrine tumours, 3) family screening of affected relatives and 4) monitoring of patients who have been diagnosed. Undiagnosed MEN1 is one of the reasons for therapeutic failure in the management of endocrine damage. Detection is therefore of major importance, and any improvement in early diagnosis can improve management.

The natural history of the disease in all its clinical forms remains poorly understood, with published studies of selected or small populations. There are still clinical forms that are difficult to link to the syndrome. These clinical forms need to be specified in order to ensure optimal management. Only a large cohort will lead to the identification of the various forms of this condition and clarify its prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in consultation

Description

Inclusion Criteria:

SYMPTOMATIC PATIENTS

  • person (adult or minor) who has not opposed participation
  • if the patient is a minor, the parents must not oppose their child's participation,
  • at least two of the three main types of lesions (parathyroid, pancreas, pituitary gland)
  • OR a known isolated tumor, main type or not, associated with the gene mutation of the NEM1 locus on chromosome 11q13
  • OR an isolated tumor, main type or not, in an individual with a confirmed family history of NEM1

ASYMPTOMATIC PATIENTS WITH A MUTATION

- Presence of a characteristic mutation of NEM1

Exclusion Criteria: NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk of occurrence of each type of MEN1 related tumors
Time Frame: Through study completion, an average of 10 years
risk of occurrence of each type of MEN1 related tumors in patients with confirmed MEN-1
Through study completion, an average of 10 years
genotype-phenotype correlation : association of specific mutations (genotype) with the clinical manifestations (phenotype)
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
overall survival
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
specific survival and life expectancy
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
age at Men1 diagnosis globally and according to the initial presentation
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
treatment description of each type of MEN1 related tumors as well as their impact on survival and on disease control
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOUDET 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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