Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03053999

Collaborator

(none)

Enrollment

Location

131.7

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Condition or Disease	Intervention/Treatment	Phase
Multiple Endocrine Neoplasia Pancreatic Neuroendocrine Tumors Hyperparathyroidism	Other: Genome Sequencing Other: Data Review

Detailed Description

Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.

Study Design

Study Type:

Observational

Anticipated Enrollment :

53 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)

Actual Study Start Date :

Oct 9, 2012

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Parathyroidectomy Tissue and Data Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors. Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).	Other: Genome Sequencing Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors. Other: Data Review Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).

Arm

Intervention/Treatment

Parathyroidectomy Tissue and Data

Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors. Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).

Other: Genome Sequencing

Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.

Other: Data Review

Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).

Outcome Measures

Primary Outcome Measures

Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing [10 years]

Secondary Outcome Measures

Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Data Review [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.