Study and Monitoring of Multiple Endocrine Neoplasia Type 1

MEN1 Clinical Trial

— NEM  

Official title:

Study and Monitoring of Multiple Endocrine Neoplasia Type 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966612
• Other study ID #: GOUDET 2018
• Status: Recruiting
• Start date: April 5, 2019
• Est. completion date: November 2029

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pierre GOUDET
• Phone: 3 80 29 56 72
• Email: pierre.goudet[@]chu-dijon.fr
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• MEN1
• Multiple Endocrine Neoplasia
• Multiple Endocrine Neoplasia Type 1

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