NCT00923780

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2009

Completed
Last Updated

July 2, 2017

Status Verified

September 28, 2009

Enrollment Period

2.7 years

First QC Date

June 17, 2009

Last Update Submit

June 30, 2017

Conditions

Keywords

Tissue AcquisitionGene ExpressionClass Predictor ModelEndocrine Tumor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 15087409BACKGROUND
  • 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.

    PMID: 14633735BACKGROUND
  • 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.

    PMID: 10221914BACKGROUND

MeSH Terms

Conditions

Endocrine Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

January 5, 2007

Primary Completion

September 28, 2009

Last Updated

July 2, 2017

Record last verified: 2009-09-28

Locations