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Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

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ClinicalTrials.gov Identifier: NCT01005654
Recruitment Status : Recruiting
First Posted : November 2, 2009
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

October 30, 2009
November 2, 2009
December 6, 2018
October 7, 2009
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To develop a genetic, epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. [ Time Frame: 10 years ]
To develop a genetic, epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study.
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Complete list of historical versions of study NCT01005654 on ClinicalTrials.gov Archive Site
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Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Background:

  • Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the United States. Furthermore, it is often difficult to distinguish between benign or malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas. More research is needed to improve detection and treatment options for patients who develop these kinds of cancer.
  • Researchers are interested in studying the molecular changes that are involved in endocrine cancer development and growth. To collect a sample of tumor specimens and healthy tissue for further study, researchers are specifically looking for samples from patients who are scheduled for surgery or biopsy on endocrine tumors.

Objectives:

- To collect samples of precancerous, cancerous, and healthy tissue from individuals who are scheduled for surgery or biopsy of endocrine system tumors.

Eligibility:

- Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National Institutes of Health Clinical Center.

Design:

  • Participants in this study will provide blood and urine samples prior to surgery.
  • During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of normal tissue near to the tumor will be removed for ongoing and future research. The rest of the tumor or growth will be sent for analysis.
  • After surgery, participants will receive routine care until discharge, and doctors will discuss possible treatment options. If there is an appropriate NIH protocol, participants may choose to be treated at the NIH.
  • After discharge, participants will return to the clinic for a routine postoperative check about 6 weeks following the operation, and then may be followed yearly at the Clinical Center or by phone.

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 difficult tumors to clinically and histopathologically distinguish as benign or malignant.
  • Moreover, endocrine neoplasm provide an extremely important model for studying the important molecular changes that lead to carcinogenesis because of their diverse clinical behavior, even when having the same TNM stage and histologic features.
  • The Endocrine Surgery Section of the Surgery Branch, NCI has a focus on studying the molecular changes that are involved in Endocrine Cancer initiation and progression. In addition, this section has primary responsibility for providing endocrine surgery consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies to help identify diagnostic and predicitive markers as well as therapeutic targets that may have significant cilinical ramifications

Objectives:

- To develop a genetic and epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.

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 nests, paragangliomas, neuroblastomas and pancreas. or patients with a described pre or potentially malignant condition that requires surgery or biopsy as a part of the standard of care treatment and/or follow up.
  • 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, and paragangliomas and or extraadrenal nests of neuroendocrine tissue.
  • At the time of surgical operation, blood samples will be obtained from the operative field during the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, and paragangliomas and or extraadrenal neuroendocrine tissue.
  • No investigational therapy will be given.
  • It is anticipated that 1350 patients will be enrolled over a period of 16 years.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Primary clinical@@@
  • Endocrine Tumors
  • Thyroid Neoplasms
  • Parathyroid Neoplasms
  • Adrenal Neoplasm
  • Neuroblastoma
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1/ Cohort 1
Subjects with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1350
Same as current
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  • INCLUSION CRITERIA:
  • Patients who have an endocrine neoplasm based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, paragangliomas, neuroblastomas and pancreas or patients with a described pre or potentially malignant condition that requires surgery or biopsy as a part of the standard of care treatment and/or follow up.
  • Patients referred to the Endocrine Consult Service on other protocol for surgical evaluation of endocrine disorders based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, 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.
  • Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.
  • Age is greater than or equal to 4 years of age.
Sexes Eligible for Study: All
4 Years to 100 Years   (Child, Adult, Older Adult)
No
Contact: Claudia P Derse-Anthony (240) 760-6102 ncieobinquiry@mail.nih.gov
Contact: Naris Nilubol, M.D. (301) 451-2355 niluboln@mail.nih.gov
United States
 
 
NCT01005654
090242
09-C-0242
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
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Principal Investigator: Naris Nilubol, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
October 12, 2018