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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03966612
Other study ID # GOUDET 2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2019
Est. completion date November 2029

Study information

Verified date June 2024
Source Centre Hospitalier Universitaire Dijon
Contact Pierre GOUDET
Phone 3 80 29 56 72
Email pierre.goudet@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date November 2029
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
Questionnaires about: Socio-professional situation Lifestyle Health NME 1 specific breast cancer survey Imaging

Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary risk of occurrence of each type of MEN1 related tumors risk of occurrence of each type of MEN1 related tumors in patients with confirmed MEN-1 Through study completion, an average of 10 years
Primary genotype-phenotype correlation : association of specific mutations (genotype) with the clinical manifestations (phenotype) Through study completion, an average of 10 years
Primary overall survival Through study completion, an average of 10 years
Primary specific survival and life expectancy Through study completion, an average of 10 years
Primary age at Men1 diagnosis globally and according to the initial presentation Through study completion, an average of 10 years
Primary treatment description of each type of MEN1 related tumors as well as their impact on survival and on disease control Through study completion, an average of 10 years
See also
  Status Clinical Trial Phase
Completed NCT00001277 - Studies of Elevated Parathyroid Activity Phase 2
Active, not recruiting NCT03043508 - Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)