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Status unknownNCT03262129MEN1-GTEcohortUpdated Aug 25, 2017

Type 1 Multiple Endocrine Neoplasia Cohort Study

An observational study in Type 1-Multiple Endocrine Neoplasia Syndrome, sponsored by Centre Hospitalier Universitaire Dijon. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study summary

Type 1 - Multiple Endocrine Neoplasia syndrome (MEN1,) is an autosomal dominant disorder secondary to MEN1 mutations that predisposes carriers to endocrine tumors. The MEN1 gene located on chromosome 11q13 encodes menin, a 610 amino acid protein expressed in all tissues tested. Menin is a scaffold protein which interacts with a large number of intracellular molecules. MEN1 disease may display various clinical associations The tumors mainly develop from endocrine tissues and may arise from parathyroid glands, duodeno-pancreas, pituitary gland, adrenal glands, and at a lower frequency from the bronchi and thymus. The penetrance is very progressive but ultimately high during a lifespan.

Although the syndrome was discovered in 1903 by Erdheim and properly documented in 1954 by Wermer, it was only in the 1970s that the variety of clinical presentations was acknowledged and first attempts to codify treatments were made. Most published studies deals with selected and small size populations. Thus, many aspects of the natural history of MEN1 remains unknown as well as the optimal care of patients. In addition, although advances in genetics improved the diagnosis of MEN1, there are still clinical forms whose attachment to the syndrome is difficult: atypical, paucisymptomatic, forms the negative genetic diagnosis (10%). These clinical forms need to be clarified to ensure optimum support.

This cohort relies on the Groupe d'étude des Tumeurs Endocrines (GTE) network for MEN1, created in February 1991, and brings together clinical centers in France and Belgium (n=80) as well as the four genetics laboratories in charge of MEN1 diagnosis. It aims at improving the knowledge of the MEN1mainly in describing:

  • its evolution over time globally and according to the initial presentation, ( particularly accounting the risk of the occurrence of secondary MEN1 related or unrelated tumors, and death)
  • the genotype-phenotype correlations and heritability of the disease
  • the real life management of patients and its impact on cure and survival for each type of MEN1-related tumor
  • the impact of the NEM on the patients' daily lives, their perception of the disease and their satisfaction with their care
02

Conditions studied

  • Type 1-Multiple Endocrine Neoplasia Syndrome
03

In context

Multiple Endocrine Neoplasia

18 studies on the registry are indexed under Multiple Endocrine Neoplasia; 5 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 629 across 11 observational studies indexed under Multiple Endocrine Neoplasia.

Browse Multiple Endocrine Neoplasia studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients followed

Eligibility criteria

Patients with MEN1 according to the Gubbio criteria :

  • Patients with a MEN1 mutation and presenting at least one of the following symptomatic or silent lesions: pHPT or pancreatic or duodenal endocrine tumor
  • Pituitary tumor
  • Adrenal tumor
  • th-NET
  • br-NET
  • And gastric enterochromaffin-like tumor (ECLoma).
  • Patients belonging to a known MEN1 family (at least one first-degree relative affected) and presenting at least one of the aforementioned lesions.
  • Patients without positive genetic testing or a family background presenting at least two of the three major MEN1 lesions (pHPT, pancreatic, or duodenal endocrine tumor, pituitary tumor).:
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Vital status

    Time frame: 12 months

  2. MEN-1 related tumors

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2012 (actual). Primary completion is estimated for Jan 2020, 96 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2016
First posted
Aug 25, 2017
StartActual
Jan 1, 2012
Primary completionEst.
Jan 2020
CompletionEst.
Dec 2020
Last update
Aug 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03262129
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Jan 1, 2012
Primary completion
Jan 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 25, 2017

Study contacts

GOUDET Pierre
Contact
pierre.goudet@chu-dijon.fr
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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