Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
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|ClinicalTrials.gov Identifier: NCT01005654|
Recruitment Status : Recruiting
First Posted : November 1, 2009
Last Update Posted : March 27, 2023
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- 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|
|Study Type :||Observational|
|Estimated Enrollment :||1900 participants|
|Official Title:||Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms|
|Actual Study Start Date :||October 7, 2009|
1/ Cohort 1
Subjects with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy
- 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.
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression, epigenetic (methylation) changes, and metabolite and protein expression. [ Time Frame: at the time of procedure or biopsy ]Obtained endocrine neoplasm tissue will be used for studies of gene expression, epigenetic (methylation) changes, and metabolite and protein expression.
- 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: at the time of procedure or biopsy ]When accessible, normal endocrine and other adjacent tissue will be obtained for comparison with the neoplastic tissue for genomic profiling to determine the best approach for normalizing expression data.
- To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, extra-adrenal neuroendocrine nests, and gastrointestinal neuroendocrine tumors for future analysis and correlation with clinical outcome. [ Time Frame: at the time of procedure or biopsy ]Obtained endocrine neoplasm tissue in the thyroid, parathyroid, adrenal, pancreas, extra-adrenal neuroendocrine nests, and gastrointestinal neuroendocrine tumors will be collected for future analysis and correlation with patient clinical outcome.
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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|
- 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.
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: Kristine J Villaruel||(240) firstname.lastname@example.org|
|Contact: Naris Nilubol, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Naris Nilubol, M.D.||National Cancer Institute (NCI)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||November 1, 2009 Key Record Dates|
|Last Update Posted:||March 27, 2023|
|Last Verified:||January 25, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.|
|Access Criteria:||Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Tissues Histological Evaluations
Establishment of Tumor Cell Lines
Metabolite and Protein Expression
Endocrine Gland Neoplasms
Adrenal Gland Neoplasms
Endocrine System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Head and Neck Neoplasms
Adrenal Gland Diseases