MEN1NEMNCT03966612
Study and Monitoring of Multiple Endocrine Neoplasia Type 1
An observational study of MEN1, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MEN1
- What is being tested?
- Questionnaires
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2019to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in consultation
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Pierre GOUDET, md, 380295672 ext. +33, pierre.goudet@chu-dijon.fr
About this study
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.
- Conditions
- MEN1
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires about:
- Socio-professional situation
- Lifestyle
- Health
- NME 1
- specific breast cancer survey
- Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of occurrence of each type of MEN1 related tumors
risk of occurrence of each type of MEN1 related tumors in patients with confirmed MEN-1
Measured: Through study completion, an average of 10 years
genotype-phenotype correlation : association of specific mutations (genotype) with the clinical manifestations (phenotype)
Measured: Through study completion, an average of 10 years
overall survival
Measured: Through study completion, an average of 10 years
specific survival and life expectancy
Measured: Through study completion, an average of 10 years
age at Men1 diagnosis globally and according to the initial presentation
Measured: Through study completion, an average of 10 years
treatment description of each type of MEN1 related tumors as well as their impact on survival and on disease control
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start5 Apr 2019
- Primary completionDec 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MEN1Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966612
- Sponsor's protocol ID
- GOUDET 2018
- Acronym
- NEM
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2019
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Monitoring of Multiple Endocrine Neoplasia Type 1
- ClinicalTrials.gov ID
- NCT03966612
- Acronym / sponsor ID
- NEM / GOUDET 2018
- Conditions
- MEN1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in consultation
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires about: * Socio-professional situation * Lifestyle * Health * NME 1 * specific breast cancer survey * Imaging | Other | – |
Primary outcome
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
genotype-phenotype correlation : association of specific mutations (genotype) with the clinical manifestations (phenotype)
Time frame: Through study completion, an average of 10 years
overall survival
Time frame: Through study completion, an average of 10 years
specific survival and life expectancy
Time frame: Through study completion, an average of 10 years
age at Men1 diagnosis globally and according to the initial presentation
Time frame: Through study completion, an average of 10 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MEN1, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre GOUDET (3 80 29 56 72 ext. +33, pierre.goudet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of occurrence of each type of MEN1 related tumors (time frame: Through study completion, an average of 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.