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RecruitingNCT03039439Updated May 22, 2026

Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

An observational study in Parathyroid Gland Adenoma, Parathyroid Gland Atypical Adenoma and Parathyroid Gland Carcinoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Nov 2015; still recruiting 10 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
310
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Parathyroid Gland Adenoma
  • Parathyroid Gland Atypical Adenoma
  • Parathyroid Gland Carcinoma
  • Primary Hyperparathyroidism
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In context

Parathyroid Neoplasms

63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.

This study's planned enrollment of 310 is above the median of 100 across 20 observational studies indexed under Parathyroid Neoplasms.

Browse Parathyroid Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients without tissue available for analysis.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
310 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 · Other: Laboratory Biomarker Analysis

Interventions

  • ProcedureBiospecimen Collection

    Previously collected tumor tissue and blood samples

  • OtherLaboratory Biomarker Analysis

    Correlative studies

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What researchers measure

Primary outcomes

  1. Biomarker levels

    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.

    Time frame: Up to 4 years

  2. Identify the potential genes that can be used in patients with parathyroid tumors for diagnostic purposes

    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.

    Time frame: Up to 4 years

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Study locations

1 of 1 sites recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
    • Nancy Perrier · Contact713-745-2168
    • Nancy Perrier · Principal investigator
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039439
Responsible party
Sponsor
First posted
Feb 1, 2017
Start date
Nov 24, 2015
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
May 22, 2026

Study contacts

Nancy D. Perrier
Contact
nperrier@mdanderson.org
713-792-6940
Nancy Perrier
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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