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 : June 12, 2018
- 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.
- To collect samples of precancerous, cancerous, and healthy tissue from individuals who are scheduled for surgery or biopsy of endocrine system tumors.
- 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.
- 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|
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- 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, our Section is uniquely positioned to acquire and perform important studies on endocrine tissue to help identify diagnostic and predictive markers, as well as, therapeutic targets that may have significant clinical ramifications. Some of the patients enrolled in this study may be on other protocols throughout the NIH, for which our Section is consulted in order to perform their operation.
- 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.
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression and epigenetic (methylation) changes, and metabolite and protein expression.
- To obtain, when accessible, normal endocrine and other adjacent tissue for comparison with the neoplastic tissue.
- To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, and extraadrenal neuroendocrine nests for future analysis and correlation with clinical outcome.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1350 participants|
|Official Title:||Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms|
|Study Start Date :||September 23, 2009|
- 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: ongoing ]
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression,epigenetic (methylation) changes, and metabolite and protein expression. [ Time Frame: ongoing ]
- To obtain, when accessible, normal endocrine and other adjacent tissue for comparison with the neoplastic tissue including the comparison of genomic profiling data to determine the best approach for normalizing expression data. [ Time Frame: ongoing ]
- 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. [ Time Frame: ongoing ]
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
|Contact: Dhaval T Patel, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Dhaval T Patel, M.D.||National Cancer Institute (NCI)|