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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 : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.

Condition or disease
Endocrine Tumors Thyroid Neoplasms Parathyroid Neoplasms Adrenal Neoplasm Neuroblastoma

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 gastrointestinal-pancreatic neuroendocrine tumors are among some of the most difficult tumors to clinically and histopathological 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 Surgical Oncology Program (formerly known as Endocrine Oncology 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, paragangliomas and/or extra adrenal nests of neuroendocrine tissue, and gastrointestinal neuroendocrine tumors.
  • 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, paragangliomas and/or extra adrenal neuroendocrine tissue and gastrointestinal neuroendocrine tumors.
  • No investigational therapy will be given.
  • It is anticipated that 1350 patients will be enrolled over a period of 16 years.

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Study Type : Observational
Estimated Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Actual Study Start Date : October 7, 2009

Resource links provided by the National Library of Medicine


Group/Cohort
1/ Cohort 1
Subjects with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical@@@
Criteria
  • 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, gastrointestinal

track 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.

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005654


Contacts
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Contact: Deborah E Allen, R.N. (240) 760-6184 ncieobinquiry@mail.nih.gov
Contact: Naris Nilubol, M.D. (240) 760-6154 niluboln@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Naris Nilubol, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01005654     History of Changes
Other Study ID Numbers: 090242
09-C-0242
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 30, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Expression
Epigenetic (methylation)
Tissues Histological Evaluations
Establishment of Tumor Cell Lines
Metabolite and Protein Expression
Adrenal Cancer
Endocrine Tumor
Thyroid Cancer

Additional relevant MeSH terms:
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Neuroblastoma
Thyroid Neoplasms
Endocrine Gland Neoplasms
Parathyroid Neoplasms
Adrenal Gland Neoplasms
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Parathyroid Diseases
Adrenal Gland Diseases