Observing and following patients with Multiple Endocrine Neoplasia Type 1
Study and Follow-up of Multiple Endocrine Neoplasia Type 1
This study is tracking people with Multiple Endocrine Neoplasia Type 1 to see how the condition develops over time in both those with symptoms and those who carry the gene but don’t have symptoms yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT03348501 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with Multiple Endocrine Neoplasia Type 1 (MEN1), a genetic condition that leads to various endocrine tumors. The study aims to gather long-term follow-up data on symptomatic individuals and asymptomatic carriers of the MEN1 mutation. Participants will be monitored for the development of clinical manifestations associated with the disease, which typically appear later in life. The research will help in understanding the progression and management of MEN1.
Who should consider this trial
Good fit: Ideal candidates include symptomatic individuals with a confirmed diagnosis of MEN1 or asymptomatic patients carrying the MEN1 mutation living in France.
Not a fit: Patients with a single-organ genetic endocrine disease associated with another genetic syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of MEN1, leading to better patient outcomes.
How similar studies have performed: While there may be studies on MEN1, this specific observational approach focusing on long-term follow-up is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Symptomatic individuals with a confirmed diagnosis of MEN1 and who live in France. Patients with the following characteristics will also be included in the cohort: * At least two of the three cardinal clinical lesions (parathyroid, pancreas, pituitary), * OR an isolated known lesion of the disease, cardinal or not (parathyroid, pancreas, pituitary, adrenal, thymus, bronchus, tumour of the central nervous system) associated with a mutation of the MEN1 locus on chromosome 11q13, * OR an isolated lesion, cardinal or not (parathyroid, pancreas, pituitary, adrenal, thymus, bronchus, tumour of the central nervous system) in an individual with a confirmed family history of MEN1. asymptomatic patients who carry a characteristic mutation of MEN1. Current knowledge suggests that these patients will develop symptoms during their follow-up. Exclusion Criteria: patients who present a single-organ genetic endocrine disease associated with another genetic syndrome (familial isolated pituitary adenoma FIPA, familial isolated hyperparathyroidism FIHP)
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Pierre GOUDET, MD
- Email: pierre.goudet@chu-dijon.fr
- Phone: 380293031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.