Gene Expression in Hyperparathyroidism

NCT03044600 | Terminated

• 1 other identifier: PA12-0944
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.To better define the differences in molecular genetics of parathyroid tumors in patients with MEN1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old.
2. 2.To better define the incidence of HRPT2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.

Conditions

Parathyroid Disease; Hyperparathyroidism

Keywords

Parathyroid disease; Hyperparathyroidism; Chart review; MEN1-negative; HRPT2 mutations

Outcome Measures

Primary Outcomes (1)

• Molecular Genetics of Parathyroid Tumors

  RNA isolated from banked frozen tissues. cDNA microarray prepared using an Illumina array chip. Results analyzed using Ingenuity analysis software to detect 2-fold changes in gene expression. T-statistics used to determine significantly discriminating genes.

  10 years

Secondary Outcomes (1)

• HRPT2 Mutations

  10 years

Study Arms (1)

Young MEN1 Negative Group

Participants under 50 years of age who have been diagnosed with MEN1-negative primary hyperparathyroidism.

Other: Chart Review; Other: HRPT2 Mutation Evaluation

Interventions

Chart Review OTHER

Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports.

Young MEN1 Negative Group

HRPT2 Mutation Evaluation OTHER

Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients stained for parafibromin to evaluate for HRPT2 mutations.

Young MEN1 Negative Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with parathyroid tumors at MD Anderson Cancer Center

You may qualify if:

• All patients previously enrolled in parathyroid tissue banking under protocol Lab08-0034.
• For the subgroup designated for HRPT2 mutation testing:
• Patients with primary hyperparathyroidism who are younger than 50 years of age and have tested negative for MEN1, between January 1, 1980 and the present.

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Parathyroid tissue previously obtained during surgery.

MeSH Terms

Conditions

Parathyroid Diseases; Hyperparathyroidism

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Nancy D. Perrier, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: November 7, 2012
• Primary Completion: October 18, 2017
• Study Completion: October 18, 2017
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

US (1)