- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039439
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nancy D. Perrier
- Phone Number: 713-792-6940
- Email: nperrier@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Nancy Perrier
- Phone Number: 713-745-2168
-
Principal Investigator:
- Nancy Perrier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
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.
|
Correlative studies
Previously collected tumor tissue and blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 4 years
|
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.
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Perrier, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA15-0928 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-01317 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Hyperparathyroidism
-
Postgraduate Institute of Medical Education and...UnknownPrimary Hyperparathyroidism (PHPT)India
-
Nantes University HospitalCompleted
-
Rambam Health Care CampusWithdrawnMultigland Disease in Primary HyperparathyroidismIsrael
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedTotal Thyroidectomy | Bilateral Neck Exploration for Primary HyperparathyroidismUnited Kingdom
-
Nantes University HospitalInstitut National de la Santé Et de la Recherche Médicale, FranceRecruiting
-
Brigham and Women's HospitalCompletedPrimary HyperparathyroidismUnited States
-
University Hospital Inselspital, BerneCompletedPrimary HyperparathyroidismSwitzerland
-
EFSTATHIOS CHRONOPOULOSCompletedPrimary Hyperparathyroidism
-
M.D. Anderson Cancer CenterUnknownPrimary HyperparathyroidismUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownPrimary Hyperparathyroidism
Clinical Trials on Laboratory Biomarker Analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed