Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

Objectives:

To contribute new and prospective data to our existing database library for patients with MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Endocrine Neoplasia Syndromes
• Intervention / Treatment: Behavioral: Questionnaires

Detailed Description

Previously followed MEN1 and MEN2 patients at M.D. Anderson Cancer Center will be mailed an introductory letter and a "consent to be contacted" form to determine whether they are interested in participating in the study. New MEN1 and MEN2 patients seen in clinic at M.D. Anderson Cancer Center will be asked if they wish to learn more about this study. Interested patients will also be asked to distribute the introductory letter and consent to be contacted form to their blood relatives. Printed materials regarding this study will only be mailed to non-MDACC individuals with the expressed written or verbal permission from a consenting MDACC patient. All interested individuals will return the signed "consent to be contacted" form to the PI. Consented individuals will be interviewed by phone and/or mail to obtain updated family and medical history specific to their diagnosis of either MEN1 or MEN2. To verify accuracy of medical data collected, all non-MDACC participants will be asked if they consent to have their off-site medical records released to us for review. There will be no treatment or collection of blood or tissue in this study.

Although this study presents minimal risk to participants, participant consent will be obtained due to the need to obtain permission to make contact with patients and their families.

Approximately 1500 patients and their relatives will be included in this study. This will be done on an inpatient and outpatient basis.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

MEN1 and MEN2 patients at M.D. Anderson Cancer Center and their relatives

Description

Inclusion Criteria:

1. Registered MDACC patients diagnosed with MEN1 or MEN2.
2. Close relatives of registered MDACC MEN patients.

Exclusion Criteria:

1. Individuals who are either non-MDACC registered patients or do not have a close relative who is an MEN patient registered at MDACC.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2; Consented individuals will be interviewed by phone and/or mail to obtain medical history specific to their diagnosis of either MEN1 or MEN2.	Behavioral: Questionnaires; Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2 Group: Participants interviewed by phone and/or mail to obtain medical history specific to their diagnosis of either MEN1 or MEN2. Close Relatives of Registered MDACC MEN Patients Group: Participants asked to complete a health and family history questionnaire. This questionnaire process may be completed by phone or mail.; Other Names: Surveys
Close Relatives of Registered MDACC MEN Patients; Participants will be asked to complete a health and family history questionnaire. This questionnaire process may be completed by phone or mail.	Behavioral: Questionnaires; Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2 Group: Participants interviewed by phone and/or mail to obtain medical history specific to their diagnosis of either MEN1 or MEN2. Close Relatives of Registered MDACC MEN Patients Group: Participants asked to complete a health and family history questionnaire. This questionnaire process may be completed by phone or mail.; Other Names: Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Contribution of New and Prospective Data to Existing Database Library for Patients with MEN1 and MEN2 by Completion of Health Questionnaires	25 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Nancy D. Perrier, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2001
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimated): February 9, 2017

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Questionnaires; Surveys; Multiple Endocrine Neoplasia Syndromes; MEN1; MEN2; Relatives; Database
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Endocrine System Diseases; Disease; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Multiple Primary; Neoplasms; Syndrome; Endocrine Gland Neoplasms; Multiple Endocrine Neoplasia
• Other Study ID Numbers: RCR01-485; NCI-2021-12213 (Other Identifier: NCI CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No