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NCT03966612Recruiting

Study and Monitoring of Multiple Endocrine Neoplasia Type 1

Source: ClinicalTrials.gov · Last updated 29 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1600 (estimated)
First submitted
11 Jan 2019
Start date
5 Apr 2019
Primary completion date
Dec 2028
Lead sponsor
Centre Hospitalier Universitaire Dijon
NCT number
NCT03966612

What you commit to

  • Study type: Observational
  • Planned participants: 1600
  • From 5 Apr 2019 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Dijon Bourgogne
Coordinator of this site? Confirm its status
DijonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.