Establishment of a Parathyroid Tissue Bank
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ClinicalTrials.gov Identifier: NCT03051126 |
Recruitment Status :
Recruiting
First Posted : February 13, 2017
Last Update Posted : January 27, 2020
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Tracking Information | |||||
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First Submitted Date | February 2, 2017 | ||||
First Posted Date | February 13, 2017 | ||||
Last Update Posted Date | January 27, 2020 | ||||
Actual Study Start Date | July 9, 2009 | ||||
Estimated Primary Completion Date | July 1, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Tissue Collection Obtained During Parathyroid and/or Pancreas Tumor Intervention to Establish a Tissue Bank Library for Ongoing Study of Parathyroid Disease and Management [ Time Frame: 15 years ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Establishment of a Parathyroid Tissue Bank | ||||
Official Title | Establishment of a Parathyroid Tissue Bank | ||||
Brief 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. | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Up to 40cc of blood will be collected from all patients during routine blood draws at follow-up appointments through the care cycle.
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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. | ||||
Condition | Parathyroid Disease | ||||
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).
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Study Groups/Cohorts | 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.
Intervention: Other: Tissue Samples
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
10000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 1, 2025 | ||||
Estimated Primary Completion Date | July 1, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: N/A |
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03051126 | ||||
Other Study ID Numbers | LAB08-0034 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | M.D. Anderson Cancer Center | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | January 2020 |