Monitoring Multiple Endocrine Neoplasia Type 1
Study and Monitoring of Multiple Endocrine Neoplasia Type 1
Centre Hospitalier Universitaire Dijon · NCT03966612
This study looks at how Multiple Endocrine Neoplasia Type 1 affects people, both those with symptoms and those without, to see how to catch it early and manage it better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Locations | 1 site (Dijon) |
| Trial ID | NCT03966612 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Multiple Endocrine Neoplasia Type 1 (MEN1), a rare genetic disorder that leads to the development of endocrine tumors. It aims to improve the understanding of the disease's natural history and enhance early diagnosis through patient monitoring and questionnaires. The study includes both symptomatic patients with specific tumor types and asymptomatic patients with known genetic mutations. By gathering data on these patients, the study seeks to inform better therapeutic management and family screening.
Who should consider this trial
Good fit: Ideal candidates include symptomatic patients with at least two types of endocrine tumors or asymptomatic patients with a known MEN1 mutation.
Not a fit: Patients without any endocrine tumors or those without a genetic mutation associated with MEN1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and management of MEN1, ultimately enhancing patient outcomes.
How similar studies have performed: While there have been limited studies on MEN1, this observational approach aims to fill gaps in understanding the disease, making it a novel effort.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Pierre GOUDET
- Email: pierre.goudet@chu-dijon.fr
- Phone: 3 80 29 56 72
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.
Conditions: MEN1