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NCT Number: NCT03966612

Study and Monitoring of Multiple Endocrine Neoplasia Type 1

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.

Recruiting

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Key information

Conditions

MEN1

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Location status: Recruiting

Location contact

Pierre GOUDET, md

CONTACT

[email protected]

380295672 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Questionnaires about:

  • Socio-professional situation
  • Lifestyle
  • Health
  • NME 1
  • specific breast cancer survey
  • Imaging

Primary outcomes

  1. risk of occurrence of each type of MEN1 related tumors

    Time frame: Through study completion, an average of 10 years

    risk of occurrence of each type of MEN1 related tumors in patients with confirmed MEN-1

  2. genotype-phenotype correlation : association of specific mutations (genotype) with the clinical manifestations (phenotype)

    Time frame: Through study completion, an average of 10 years

  3. overall survival

    Time frame: Through study completion, an average of 10 years

  4. specific survival and life expectancy

    Time frame: Through study completion, an average of 10 years

  5. age at Men1 diagnosis globally and according to the initial presentation

    Time frame: Through study completion, an average of 10 years

  6. treatment description of each type of MEN1 related tumors as well as their impact on survival and on disease control

    Time frame: Through study completion, an average of 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre GOUDET

CONTACT

[email protected]

3 80 29 56 72 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: NEM

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
May 29, 2019
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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