Establishment of a Parathyroid Tissue Bank

To develop a tissue bank library for patients with parathyroid disease who have undergone surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer Center or outside centers, and/or all patients seen through the Parathyroid Center at participating sites, whether or not the patients undergo treatment for their disease. The tissue bank will contain both normal parathyroid tissue and diseased tissue, and will provide a resource for the ongoing study of parathyroid disease and management.

Study Overview

• Status: Recruiting
• Conditions: Parathyroid Disease
• Intervention / Treatment: Other: Tissue Samples

Detailed Description

Fresh residual tissue samples will be obtained during parathyroid and/or pancreas tumor intervention (for pancreas tumor intervention in MEN1 patients with hyperparathyroidism and pancreatic lesions).

In addition, outside paraffin tissue blocks or slides will be requested from patients presenting to MDACC, or to participating family members who have had prior surgery outside of MD Anderson.

Forty cubic centimeters (40 ccs) of whole blood will be obtained from individuals for peripheral blood lymphocyte, plasma, and serum separation and analysis per event. Collections may be made at any or all of the following timepoints: preoperatively, during intervention, and/or at subsequent follow-up visits for up to fifteen years.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Nancy D. Perrier, MD; Phone Number: 713-792-6940; Email: NPerrier@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tissue bank library for patients with parathyroid disease who have undergone surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer Center or outside centers, and/or all patients seen through the Parathyroid Center at participating sites, whether or not the patients undergo treatment for their disease.

Description

Inclusion Criteria:

1. Eligible participants will include patients presenting at MD Anderson Cancer who are scheduled for surgical treatment of parathyroid disease and/or patients with MEN1, and/or those presenting with hyperparathyroidism and/or pancreatic lesion, who are scheduled for pancreas tumor intervention, as well as patients having had surgery and who have had residual tissue stored under LAB02-518, LAB03-0320 or prior front door consents, or who have had surgery at other centers and provide signed authorization to obtain the tissue from the outside institution.
2. In addition, eligible participants may include family members of MD Anderson patients who have been diagnosed with parathyroid disease and who have had surgery at other centers, and who provide a signed authorization to obtain the tissue from outside facilities AND/OR who begin care at MD Anderson and will be having intervention at MD Anderson.

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parathyroid Disease Tissue Bank; Participants scheduled for surgical treatment of parathyroid disease and/or patients with MEN1, and/or those presenting with hyperparathyroidism and/or pancreatic lesion, who are scheduled for pancreas tumor intervention.	Other: Tissue Samples; Fresh residual tissue samples will be obtained during parathyroid and/or pancreas tumor intervention (for pancreas tumor intervention in MEN1 patients with hyperparathyroidism and pancreatic lesions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tissue Collection Obtained During Parathyroid and/or Pancreas Tumor Intervention to Establish a Tissue Bank Library for Ongoing Study of Parathyroid Disease and Management	15 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Nancy D. Perrier, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2009
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Database; Parathyroid disease; Parathyroid Tissue Bank; Blood samples
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases
• Other Study ID Numbers: LAB08-0034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No