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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Previously collected tumor tissue and blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 years |
| 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. | Up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy D. Perrier | Contact | 713-792-6940 | nperrier@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Perrier | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Tumor tissue, blood
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D006961 | Hyperparathyroidism |
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