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NCT03053999 Clinical Trial

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

Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03053999
Other study ID # PA12-0892
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2012
Est. completion date October 2023

Study information
Verified date September 2019
Source M.D. Anderson Cancer Center
Contact Nancy D. Perrier, MD
Phone 713-792-6940
Email NPerrier@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 53
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.

2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.

Exclusion Criteria:

N/A

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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).

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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Completed NCT02524041 - Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism N/A
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