Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)
NCT ID: NCT03043508
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
45 participants
OBSERVATIONAL
2015-04-10
2026-04-01
Brief Summary
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The primary objective of this study is to evaluate the effect of estrogen on the development of the PNET in MEN1 patients.
The secondary objective is to evaluate the overall survival and disease specific survival in patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor in relation to their hormone status. The secondary objective is to evaluate clinicopathologic features in relation to hormone status.
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Detailed Description
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For the prospective portion of this study, investigators want to see the impact of estrogen on the PNET forming and progression, and would like to use two equations to assess the estrogen exposure, so investigators should collect the information of menopause, menarche, breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female patients in the database who are still living, and obtain verbal informed consent to send an email questionnaire regarding their pregnancy and hormone use history.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Participants With Confirmed MEN1 With PNET
Retrospective review of a prospectively maintained MEN1 database.
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Chart Review
Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.
Questionnaire
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Participants With Confirmed MEN1 Without PNET
Retrospective review of a prospectively maintained MEN1 database.
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Chart Review
Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.
Questionnaire
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Interventions
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Chart Review
Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.
Questionnaire
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
3. All patients for whom hormone status variables and survival data are available will be included.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy D. Perrier, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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PA15-0231
Identifier Type: -
Identifier Source: org_study_id
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