Lesions Clinical Trial
Official title:
Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms
Background:
- Tumors depend on blood vessels to provide the nourishment that allows them to grow.
- Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the
tumors that contain the most blood vessels. Thus, endocrine tumors are important for the
study of new blood vessel formation in tumors.
Objectives:
-To obtain tissues from endocrine tumors for examination to determine how they differ from
normal tissue.
Eligibility:
-Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the
thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.
Design:
- Tissues will be obtained from patients during surgery to remove thyroid, parathyroid,
adrenal, pancreas, or neuroendocrine tumors.
- About 400 patients will be enrolled in the study over a period of 5 years.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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