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Tumor Angiogenesis in Patients With Endocrine Tumors
This study has been completed.
First Received: May 9, 2009   Last Updated: October 7, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00898729
  Purpose

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.


Condition Intervention
Adrenocortical Carcinoma
Head and Neck Cancer
Islet Cell Tumor
Multiple Endocrine Neoplasia
Neoplastic Syndrome
Neuroblastoma
Pheochromocytoma
Von Hippel-Lindau Syndrome
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

Study Type: Observational
Official Title: Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Development of a class prediction model [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2007
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898729

Sponsors and Collaborators
Investigators
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000531068, NCI-07-C-0060, NCI-P7004
Study First Received: May 9, 2009
Last Updated: October 7, 2009
ClinicalTrials.gov Identifier: NCT00898729     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I follicular thyroid cancer
stage II follicular thyroid cancer
stage III follicular thyroid cancer
stage IV follicular thyroid cancer
stage I papillary thyroid cancer
stage II papillary thyroid cancer
stage III papillary thyroid cancer
stage IV papillary thyroid cancer
recurrent thyroid cancer
recurrent islet cell carcinoma
multiple endocrine neoplasia
recurrent parathyroid cancer
recurrent pheochromocytoma
insulinoma
localized parathyroid cancer
metastatic parathyroid cancer
von Hippel-Lindau syndrome
parathyroid chief cell adenoma
parathyroid mixed cell type adenoma
parathyroid transitional clear cell adenoma
localized benign pheochromocytoma
metastatic pheochromocytoma
regional pheochromocytoma
disseminated neuroblastoma
localized resectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma
recurrent adrenocortical carcinoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive
Angiomatosis
Pancreatic Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Multiple Primary
Adrenal Gland Diseases
Pheochromocytoma
Neuroblastoma
Paraganglioma
Pathologic Processes
Neoplasms by Site
Von Hippel-Lindau Disease
Neoplasms, Germ Cell and Embryonal
Syndrome
Cardiovascular Diseases
Adrenal Cortex Neoplasms
Multiple Endocrine Neoplasia
Endocrine Gland Neoplasms
Neurocutaneous Syndromes
Digestive System Neoplasms
Disease
Neoplasms by Histologic Type
Adrenocortical Carcinoma
Nervous System Diseases
Vascular Diseases
Endocrine System Diseases
Adenoma, Islet Cell
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on February 08, 2010