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Clinical Trial NCT03348501 (GENEM) for Multiple Endocrine Neoplasia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study and Follow-up of Multiple Endocrine Neoplasia Type 1 (GENEM) 2,000 Rare Disease

Recruiting
Clinical Trial NCT03348501 (GENEM) is an observational study for Multiple Endocrine Neoplasia that is recruiting. It started on 1 July 2012 with plans to enroll 2,000 participants. Led by Centre Hospitalier Universitaire Dijon, it is expected to complete by 1 July 2031. The latest data from ClinicalTrials.gov was last updated on 21 November 2017.
Brief Summary
Multiple Endocrine Neoplasia type I (MEN1) or Wermer syndrome is an autosomal dominant disease that predisposes patients to the development of endocrine tumours, principally parathyroid, pituitary or duodenal-pancreatic tumours. It is due to mutations that abolish the function of the MEN1 gene, which contributes to tumour regulation. It is a rare disease, with an estimated prevalence in the general population of 1/30...Show More
Official Title

Study and Follow-up of Multiple Endocrine Neoplasia Type 1

Conditions
Multiple Endocrine Neoplasia
Other Study IDs
  • GENEM
  • GOUDET PARI2011
NCT ID Number
NCT03348501
Start Date (Actual)
2012-07
Last Update Posted
2017-11-21
Completion Date (Estimated)
2031-07
Enrollment (Estimated)
2,000
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
survey for long-term follow-up of the disease
patients will be regularly asked about their state of health (occurrence of a major health event that required hospitalization, for example ...), and about their living conditions (alcohol and tobacco consumption, socio-economic environment). Questionnaires of quality of life and satisfaction related to care will also be offered at regular intervals to better know the impact of their disease on their daily lives and ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Questionnaire or Life quality
through study completion, an average of 19 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All

- 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.

patients who present a single-organ genetic endocrine disease associated with another genetic syndrome (familial isolated pituitary adenoma FIPA, familial isolated hyperparathyroidism FIHP)
Centre Hospitalier Universitaire Dijon logoCentre Hospitalier Universitaire Dijon
Study Central Contact
Contact: Pierre GOUDET, MD, 380293031, [email protected]
1 Study Locations in 1 Countries
CHU Dijon Bourgogne, Dijon, 21079, France
Pierre GOUDET, md, Contact, 380293031, [email protected]
Recruiting