## Protocol Section
### Identification Module
**NCT ID:** NCT03048279

**Brief Title:** Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

**Official Title:** Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

#### Organization Study ID Info
**ID:** RCR01-485
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI CTRP Clinical Trials Reporting Registry
**ID:** NCI-2021-12213
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-10

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2001-09-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2017-02-09
**Type:** ESTIMATED
**Study First Submit Date:** 2017-02-07
**Study First Submit QC Date:** 2017-02-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Multiple Endocrine Neoplasia Syndromes

**Keywords:**

- Multiple Endocrine Neoplasia Syndromes

- MEN1

- MEN2

- Relatives

- Database

- Questionnaires

- Surveys

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Consented individuals will be interviewed by phone and/or mail to obtain medical history specific to their diagnosis of either MEN1 or MEN2.

**Intervention Names:**

- Behavioral: Questionnaires

**Label:** Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

#### Arm Group 2

**Description:** Participants will be asked to complete a health and family history questionnaire. This questionnaire process may be completed by phone or mail.

**Intervention Names:**

- Behavioral: Questionnaires

**Label:** Close Relatives of Registered MDACC MEN Patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Close Relatives of Registered MDACC MEN Patients

- Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

**Description:** 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.

**Name:** Questionnaires

**Other Names:**

- Surveys

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Contribution of New and Prospective Data to Existing Database Library for Patients with MEN1 and MEN2 by Completion of Health Questionnaires

**Time Frame:** 25 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** MEN1 and MEN2 patients at M.D. Anderson Cancer Center and their relatives

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** University of Texas MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Nancy D. Perrier, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** University of Texas MD Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000009378

- Term: Neoplasms, Multiple Primary

- ID: D000009386

- Term: Neoplastic Syndromes, Hereditary

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: HIGH

- As Found: Endocrine Neoplasia

- ID: M12322

- Name: Multiple Endocrine Neoplasia

- Relevance: HIGH

- As Found: Multiple Endocrine Neoplasia

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12323

- Name: Neoplasms, Multiple Primary

- Relevance: LOW

- As Found: Unknown

- ID: M12331

- Name: Neoplastic Syndromes, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T3935

- Name: Multiple Endocrine Neoplasia Type 2

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009377

- Term: Multiple Endocrine Neoplasia

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
