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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Time to Pancreatic Neuroendocrine Tumors (PNET) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET [ Time Frame: 10 years ]

Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: February 2, 2017
Date Started: April 10, 2015
Date Completion: April 1, 2025
Last Updated: February 3, 2017
Last Verified: February 2017