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Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms


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Trial Information

Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms


Background:

- Endocrine neoplasms are among the fastest growing tumors in incidence in the United
States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98
percent.

- Tumors of the thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors
are among some of the most highly vascularized tumors seen.

- Consequently, endocrine neoplasms provide an extremely important model for the study of
tumor angiogenesis.

- The Tumor Angiogenesis Section of the Surgery Branch, NCI has a focus on studying
neovascular formation in neoplastic tissues. In addition, this section has primary
responsibility for providing endocrine surgery consultative services to the NIH. As
such, our Section is uniquely positioned to acquire and perform important studies on
endocrine tissue to help advance our knowledge of the mechanisms involved in tumor
vessel development. The majority of the patients enrolled on this study will be
patients on other protocols throughout the NIH, for which our Section is consulted in
order to perform their surgery.

Objectives:

Primary Objective:

-To develop a class predictor model based on gene expression patterns to distinguish benign
from neoplastic endocrine tissue for each of the endocrine histologies under study. This
objective will drive the statistical endpoints of the study.

Secondary Objectives:

- To utilize the tissue obtained from these endocrine neoplasms for studies of gene
expression changes, proteomic changes, and methylation changes.

- To perform histologic examination of these tissues including immunohistochemistry and
in situ hybridization in order to study changes in tumor neovessel formation.

- To obtain, when accessible, adjacent normal endocrine tissue for comparison with the
neoplastic tissue.

- To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid,
adrenal, pancreas, and extraadrenal neuroendocrine rests for future analysis and
correlation with clinical outcome.

Eligibility:

- Patients with radiographic evidence of, biochemical evidence of, or
histologically/cytologically proven, endocrine neoplasms, including lesions of the
thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, paragangliomas,
neuroblastomas and pancreas.

- Patients must have an ECOG performance score of 0-2.

- Patients must have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to biopsy or surgery.

Design:

- A tissue acquisition trial in which tissues will be obtained at the time of surgical
operation for the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas,
paragangliomas and or extraadrenal rests of neuroendocrine tissue.

- Tissue will be processed at the time of collection, stored and then shipped to the PI's
laboratory for further processing.

- No investigational therapy will be given.

- It is anticipated that 400 patients will be enrolled over a period of 5 years.

Inclusion Criteria


- INCLUSION CRITERIA:

- Patients referred to the Endocrine Consult Service with radiographic evidence of,
biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms,
including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine
rests, paragangliomas, neuroblastomas and pancreas.

- Patients must have an ECOG performance score of 0-2.

- Patients must have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to biopsy or surgery.

- Patients undergoing treatment for their neoplasm may be eligible.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Authority:

United States: Federal Government

Study ID:

070060

NCT ID:

NCT00923780

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Lesions
  • Tissue Acquisition
  • Gene Expression
  • Class Predictor Model
  • Endocrine Tumor
  • Endocrine Gland Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892