Tumor Angiogenesis in Patients With Endocrine Tumors

Official Title: “Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms”

RATIONALE: Studying samples of tissue from patients with endocrine tumors in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tissue samples from patients with endocrine tumors to evaluate tumor blood vessel growth.

OBJECTIVES:

Primary - Develop a class predictor model for each of the histologies under study, based on gene expression patterns, to distinguish benign from neoplastic endocrine tissue in patients with endocrine tumors.

Secondary - Utilize the tissue obtained from these endocrine neoplasms for studies of gene expression changes, proteomic changes, and methylation changes in these patients. - Perform histologic examination of these tissues, including immunohistochemistry and in situ hybridization, in order to study changes in tumor neovessel formation in these patients. - Obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue in these patients. - Collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal glands, pancreas, and extra-adrenal neuroendocrine rests for future analysis and correlation with clinical outcome in these patients.

OUTLINE: Patients undergo surgery for removal of endocrine tumor tissue and normal tissue for biological/laboratory studies. Samples are analyzed to evaluate tumor angiogenesis using RNA in situ hybridization, DNA methylation analysis, gene expression profiling, reverse transcriptase-polymerase chain reaction, and immunohistochemistry.

After completion of study procedures, patients are followed at 2 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Genetic: DNA methylation analysis
• Genetic: in situ hybridization
• Genetic: microarray analysis
• Genetic: reverse transcriptase-polymerase chain reaction
• Other: immunohistochemistry staining method
• Other: laboratory biomarker analysis
• Procedure: biopsy

Primary Measures

• Development of a class prediction model
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed or radiographic or biochemical evidence of endocrine neoplasm, including any of the following:
• Thyroid tumor (e.g., papillary thyroid cancer, follicular variant of papillary thyroid cancer, follicular cancer, hyperplastic neoplasm, or adenoma)
• Parathyroid tumor (e.g., sporadic adenoma, multiple endocrine neoplasia 1
• [MEN1]-related adenoma, familial adenoma, or parathyroid cancer)
• Adrenal tumor (e.g., pheochromocytoma, aldosteronoma, cortisol adenoma, adrenal hyperplasia, primary pigmented nodular adrenocortical disease, or adrenal cortical cancer)
• Extra-adrenal neuroendocrine rests
• Pancreatic neuroendocrine tumors associated with von Hippel-Lindau syndrome or MEN1, insulinoma, gastrinoma, or nonfunctional tumors
• Paragangliomas or carotid body tumors
• Neuroblastomas

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery

PRIOR CONCURRENT THERAPY:

• Concurrent treatment for neoplasm allowed

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Cancer Institute (NCI) NIH

Overall Clinical Trial Officials and Contacts

Steven A. Rosenberg, MD, PhD Principal Investigator NCI - Surgery Branch  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00898729

Study ID Number: CDR0000531068

ClinicalTrials.gov Identifier: NCT00898729

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database