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Molecular and Immunohistochemical Profiling of Parathyroid Tumors

This observational study is looking at parathyroid tumors, including parathyroid gland adenoma (a non-cancerous tumor), atypical adenoma, and carcinoma (cancer). Researchers are studying previously collected tumor tissue and blood samples through molecular and immunohistochemical profiling. This involves analyzing the samples in the lab to identify potential genes that could help doctors diagnose parathyroid tumors more accurately. The goal is to improve diagnosis, avoid unnecessary surgeries, and reduce patient stress. This study aims to understand the differences between various types of parathyroid tumors and find better diagnostic tools. The study plans to include 310 participants, and its current status is unclear.

Study design
This is an observational study that will analyze previously collected samples from 310 participants. It is not a treatment study.
What's involved
This study uses previously collected tumor tissue and blood samples, so participants do not need to undergo new procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will measure biomarker levels and identify potential diagnostic genes for up to 4 years.

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NCT03039439

Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

Recruiting
Not specifiedAll AgesObservational
M.D. Anderson Cancer Center
~310 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionLaboratory Biomarker Analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biomarker levels
Measured over Up to 4 years
+1 more outcome measured

Conditions

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

Explore related trials

Atypical Parathyroid Gland TumorParathyroid Gland AdenomaParathyroid Gland CarcinomaPrimary Hyperparathyroidism

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Nancy Perrier · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Nancy D. Perrier
[email protected]
713-792-6940
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Patients without tissue available for analysis.

What this trial measures

  • Biomarker levelsUp 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.

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