- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923780
Evaluation of Blood Vessel Formation in Endocrine Tumors
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mazzanti C, Zeiger MA, Costouros NG, Umbricht C, Westra WH, Smith D, Somervell H, Bevilacqua G, Alexander HR, Libutti SK. Using gene expression profiling to differentiate benign versus malignant thyroid tumors. Cancer Res. 2004 Apr 15;64(8):2898-903. doi: 10.1158/0008-5472.can-03-3811. Erratum In: Cancer Res. 2004 Jul 15;64(14):5028. Costourous N [corrected to Costouros NG].
- Libutti SK, Crabtree JS, Lorang D, Burns AL, Mazzanti C, Hewitt SM, O'Connor S, Ward JM, Emmert-Buck MR, Remaley A, Miller M, Turner E, Alexander HR, Arnold A, Marx SJ, Collins FS, Spiegel AM. Parathyroid gland-specific deletion of the mouse Men1 gene results in parathyroid neoplasia and hypercalcemic hyperparathyroidism. Cancer Res. 2003 Nov 15;63(22):8022-8.
- Bergers G, Javaherian K, Lo KM, Folkman J, Hanahan D. Effects of angiogenesis inhibitors on multistage carcinogenesis in mice. Science. 1999 Apr 30;284(5415):808-12. doi: 10.1126/science.284.5415.808.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 070060
- 07-C-0060
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 Lesions
-
Cynosure, Inc.CompletedBenign Pigmented Lesions | Wrinkle | Benign Vascular LesionsUnited States
-
Rigshospitalet, DenmarkCompletedFocal Liver Lesions | Focal Lesions in the AbdomenDenmark
-
Orthopaedic Research FoundationGenzyme, a Sanofi CompanyCompletedChondrosis | Patellar Articular Cartilage Lesions | Trochlear Articular Cartilage LesionsUnited States
-
University Hospital, GrenobleCompletedRandomized Controlled Trials | Vacuum Extraction, Obstetrical | Failures, Medical Device | Maternal Lesions | Neonatal LesionsFrance
-
Sohag UniversityRecruitingEsophageal LesionsEgypt
-
M.D. Anderson Cancer CenterNational Institute of Dental and Craniofacial Research (NIDCR)Recruiting
-
Cairo UniversityNot yet recruiting
-
M.D. Anderson Cancer CenterRecruitingBreast LesionsUnited States
-
University of FloridaJohns Hopkins University; Mayo Clinic; Yale University; Columbia University; Ochsner... and other collaboratorsCompletedGastroenterology | LesionsUnited States
-
GE HealthcareCompletedLiver LesionsChina, Korea, Republic of, Taiwan