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Clinical Trial NCT01005654 for Endocrine Tumors, Thyroid Neoplasms, Parathyroid Neoplasms, Adrenal Neoplasm, Neuroblastoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms 2,415

Recruiting
Clinical Trial NCT01005654 is an observational study for Endocrine Tumors, Thyroid Neoplasms, Parathyroid Neoplasms, Adrenal Neoplasm, Neuroblastoma that is recruiting. It started on 7 October 2009 with plans to enroll 2,415 participants. Led by National Cancer Institute (NCI), it is expected to complete by N/A. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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 stu...
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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,...

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Official Title

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Conditions
Endocrine TumorsThyroid NeoplasmsParathyroid NeoplasmsAdrenal NeoplasmNeuroblastoma
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 090242
  • 09-C-0242
NCT ID Number
NCT01005654
Start Date (Actual)
2009-10-07
Last Update Posted
2026-03-27
Enrollment (Estimated)
2,415
Study Type
Observational
Status
Recruiting
Keywords
Gene Expression
Epigenetic (methylation)
Tissues Histological Evaluations
Establishment of Tumor Cell Lines
Metabolite and Protein Expression
Natural History
Adrenal Cancer
Endocrine Tumor
Thyroid Cancer
Arms / Interventions
Participant Group/ArmIntervention/Treatment
1/ Cohort 1
Participants with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 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.
10 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression, epigenetic (methylation) changes, and metabolite and protein expression.
Obtained endocrine neoplasm tissue will be used for studies of gene expression, epigenetic (methylation) changes, and metabolite and protein expression.
at the time of procedure or biopsy
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.
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.
at the time of procedure or biopsy
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.
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.
at the time of procedure or biopsy
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
4 Years
Eligible Sexes
All
  • Participants 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 participants 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.

  • Participants referred to the Endocrine Consult Service on other protocols 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.
  • Participants must have an ECOG performance score of 0-2.
  • Participants must have physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
  • Participants must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Participants will not be enrolled exclusively for the procurement of tissue samples.
  • Age >= 4 years of age.

None.
National Cancer Institute (NCI) logoNational Cancer Institute (NCI)3019 active studies to explore
Study Central Contact
Contact: Kristine J Villaruel, (240) 858-7033, [email protected]
Contact: Naris Nilubol, M.D., (240) 760-6154, [email protected]
1 Study Locations in 1 Countries

Maryland

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
Recruiting