Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)

Active, not recruiting

• Conditions: Genetic Mutation; MEN1
• Interventions: Other: Chart Review; Behavioral: Questionnaire

• Registration Number: NCT03043508
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

OBJECTIVES:

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.

Detailed Description

Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists of all patients with confirmed MEN1 with or without PNET who are included in the database. The database will be 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.

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.

Study Timeline

• Study Start: 2015-04-10
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1. The patient cohort for this study consists of all patients within the prospectively maintained MEN1 database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
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

1. Due to the nature of the questions included in the prospective estrogen questionnaire, only female patients will be verbally consented to receive the questionnaire and obtain prospective data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With Confirmed MEN1 With PNET	Questionnaire	Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Participants With Confirmed MEN1 With PNET	Chart Review	Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Participants With Confirmed MEN1 Without PNET	Chart Review	Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Participants With Confirmed MEN1 Without PNET	Questionnaire	Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Primary Outcome Measures

Name	Time	Method
Time to Pancreatic Neuroendocrine Tumors (PNET)	10 years	Time to PNET calculated starting from the date of menarche time to the PNET diagnostic date or the menopause date (for the patients who get the menopause prior to the PNET diagnosis) or the last follow-up date.

Secondary Outcome Measures

Name	Time	Method
Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET	10 years	Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States