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Recruiting NCT03039439

Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

Observational Parathyroid Gland Adenoma Parathyroid Gland Atypical Adenoma Parathyroid Gland Carcinoma Primary Hyperparathyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Laboratory Biomarker Analysis.
Who it may be relevant to
Registry conditions: Parathyroid Gland Adenoma, Parathyroid Gland Atypical Adenoma, Parathyroid Gland Carcinoma, Primary Hyperparathyroidism. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Molecular and Immunohistochemical Profiling of Tumor From Patients With Parathyroid Tumors for Evaluation of Targeted Agents

Overview

This trial studies molecular and immunohistochemical profiling of tumors in patients with parathyroid tumors. Studying molecular and immunohistochemical profiling of tumors may help doctors avoid inconsistencies in diagnosis, unnecessary or incomplete surgery, surgical morbidity, psychological stress, and inadequate follow up.

Detailed description

PRIMARY OBJECTIVES:

I. To determine the differences in clinical behavior and immunohistochemical (IHC) biomarkers between parathyroid carcinoma (PC), atypical neoplasm (AN) and parathyroid adenoma (PA).

II. To determine which potential genes can be used in patients with parathyroid tumors for diagnostic purposes.

OUTLINE:

Previously collected tumor tissue and blood samples are analyzed via immunohistochemical profiling for identifying potential genes showing molecular aberrations as other types of cancer.

Interventions

  • Procedure Biospecimen Collection
    Previously collected tumor tissue and blood samples
  • Other Laboratory Biomarker Analysis
    Correlative studies

Primary outcome measures

  • Biomarker levels [Time frame: Up to 4 years]
  • Identify the potential genes that can be used in patients with parathyroid tumors for diagnostic purposes [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • The patient cohort for this study consists of all patients within the prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center (MDACC) or from collaborating sites, with tissue or blood available from 1968-2015, previously consented for the use of the tissue for research purposes (via Protocols LAB 08-0034, PA11-0695 and LAB03-0320 or the appropriate external mechanism for collaborating sites).
  • All patients with a known diagnoses of primary hyperparathyroidism (PHPT) operated/treated in the Department of Surgical Oncology of MDACC or at a collaborating site. Patients that have provided consent for the use of the tissue or blood for research purposes will then be considered for our study (via Protocol LAB03-0320 and LAB 08-0034 or the appropriate external mechanism for collaborating sites).
  • All consented patients with known diagnoses of PHPT with a histopathological diagnosis of: parathyroid carcinoma, atypical parathyroid neoplasm or parathyroid adenoma. There will be no restrictions on age, gender, or ethnicity.
  • Selected patients obtained through outside collaboration who meet the selection criteria for tissue availability and diagnostic suitability for inclusion in the study.

Exclusion criteria

  • Patients without tissue available for analysis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT03039439 · PA15-0928 · NCI-2018-01317 · PA15-0928 · P30CA016672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗