Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Parathyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Primary Hyperparathyroidism

Parathyroid Carcinoma

All Drugs and Chemicals

Parathyroid Hormone

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

Previously collected tumor tissue and blood samples

Biospecimen Collection

Laboratory Biomarker Analysis

Nancy D. Perrier

Nancy Perrier

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.

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.

Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

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

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.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Hormones

Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.

Parathyroidectomy

Moshim Kukar

This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.

PRIMARY OBJECTIVES:

I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).

SECONDARY OBJECTIVES:

I. Cost-analysis to determine savings of omission of intraoperative PTH testing.

OUTLINE:

Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.

After completion of study, patients are followed up at 2 weeks.

Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism

Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism

Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.

cost analysis will be based on operative time and omission of intraoperative PTH levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors	NCT03039439	Parathyroid Gla... Parathyroid Gla... Parathyroid Gla... Primary Hyperpa...	Biospecimen Col... Laboratory Biom...	-	M.D. Anderson Cancer Center
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism	NCT03011736	Parathyroid Gla... Primary Hyperpa...	Laboratory Biom... Parathyroidecto...	18 Years -	Roswell Park Cancer Institute
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism	NCT03011736	Parathyroid Gla... Primary Hyperpa...	Laboratory Biom... Parathyroidecto...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for parathyroid gland adenoma