Establishment of a Parathyroid Tissue Bank

Parathyroid Disease Clinical Trial

Official title:

Establishment of a Parathyroid Tissue Bank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03051126
• Other study ID #: LAB08-0034
• Status: Recruiting
• Start date: July 9, 2009
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2020
• Source: M.D. Anderson Cancer Center
• Contact: Nancy D. Perrier, MD
• Phone: 713-792-6940
• Email: NPerrier[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parathyroid Disease
• Parathyroid Diseases

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).

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	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

External Links

•   University of Texas MD Anderson Cancer Center Website