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Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039439
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Parathyroid Gland Adenoma Parathyroid Gland Atypical Adenoma Parathyroid Gland Carcinoma Primary Hyperparathyroidism Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

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.

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Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular and Immunohistochemical Profiling of Tumor From Patients With Parathyroid Tumors for Evaluation of Targeted Agents
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


Group/Cohort Intervention/treatment
Ancillary-Correlative (laboratory biomarker analysis)
Previously collected tumor tissue and blood samples are analyzed via immunohistochemical profiling for identifying potential genes showing molecular aberrations as other types of cancer.
Procedure: Biospecimen Collection
Previously collected tumor tissue and blood samples

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Biomarker levels [ Time Frame: Up to 4 years ]
    Will be reported as 0 (negative), 1 (low intensity), 2 (medium intensity), or 3 (high intensity). Sensitivity, specificity, and accuracy will be reported for each cutoff for each biomarker separately to categorize tumor types. Receiver operating characteristic (ROC) analysis will be employed to graphically summarize the tradeoffs between sensitivity and specificity for different cutoffs. Several different combinations of tumor types are of interest: parathyroid carcinoma (PC) versus (vs.) atypical neoplasm (AN), PC vs. parathyroid adenoma (PA), PN vs. PA, PC/AN vs. PA, and PC vs. AN/PA. Separately analyses will be performed for each. Following univariable analyses, a multivariable logistic regression model will be fit (again, separately for each combination of tumor types) to assess the ability of multiple markers to classify patients, and ROC analysis will also be used to summarize the performance of the resulting model.

  2. Identify the potential genes that can be used in patients with parathyroid tumors for diagnostic purposes [ Time Frame: Up to 4 years ]
    Genomic analysis of tumor samples will be performed to identify molecular aberrations for which novel targeted therapies have been recently developed. Statistical analyses will be conducted by using 2-sample t-test. Other appropriate statistical methods may also be employed (e.g., non-parametric tests, analysis of variance [ANOVA], or statistical classifications) depending on the endpoint and research interest.


Biospecimen Retention:   Samples With DNA
Tumor tissue, blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants in 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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039439


Contacts
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Contact: Nancy D. Perrier 713-792-6940 nperrier@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Nancy Perrier    713-745-2168      
Principal Investigator: Nancy Perrier         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nancy Perrier M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03039439    
Other Study ID Numbers: PA15-0928
NCI-2018-01317 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA15-0928 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms