NCT03043508

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

10 years

First QC Date

February 2, 2017

Last Update Submit

May 21, 2019

Conditions

Genetic MutationMEN1

Keywords

Genetic mutationMEN1Pancreatic neuroendocrine tumorPNETChart reviewQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Time to Pancreatic Neuroendocrine Tumors (PNET)

    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.

    10 years

Secondary Outcomes (1)

  • Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET

    10 years

Study Arms (2)

Participants With Confirmed MEN1 With PNET

Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Other: Chart ReviewBehavioral: Questionnaire

Participants With Confirmed MEN1 Without PNET

Retrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Other: Chart ReviewBehavioral: Questionnaire

Interventions

Chart ReviewOTHER

Database 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.

Participants With Confirmed MEN1 With PNETParticipants With Confirmed MEN1 Without PNET
QuestionnaireBEHAVIORAL

Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Also known as: Survey
Participants With Confirmed MEN1 With PNETParticipants With Confirmed MEN1 Without PNET

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospectively maintained MEN1 database within the Department of Surgical Oncology, Division of Surgical Endocrinology at the University of Texas MD Anderson Cancer Center.

You may qualify if:

  • 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.
  • Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
  • All patients for whom hormone status variables and survival data are available will be included.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Adenoma, Islet CellNeuroectodermal Tumors, Primitive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nancy D. Perrier, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 6, 2017

Study Start

April 10, 2015

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

US(1)