Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

Multiple Endocrine Neoplasia Syndromes Clinical Trial

Official title:

Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03048279
• Other study ID #: RCR01-485
• Secondary ID: NCI-2021-12213
• Status: Active, not recruiting
• Start date: September 5, 2001
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Multiple Endocrine Neoplasia
• Multiple Endocrine Neoplasia Syndromes
• Neoplasms
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contribution of New and Prospective Data to Existing Database Library for Patients with MEN1 and MEN2 by Completion of Health Questionnaires		25 years

External Links

•   University of Texas MD Anderson Cancer Center