Clinical trial · Observational
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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 participants 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....
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Neoplasm | Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Endocrine Tumors | Endocrine Neoplasm | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Parathyroid Neoplasms | Parathyroid Gland Neoplasm | ALIAS | 0.90 |
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1/ Cohort 1
- description
- Participants with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 10 years
- description
- 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.
Secondary outcomes (3)
- measure
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression, epigenetic (methylation) changes, and metabolite and protein expression.
- timeFrame
- at the time of procedure or biopsy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA: None.
References
Publications (4)
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106. PMID 16514137
- BACKGROUNDLee PK, Jarosek SL, Virnig BA, Evasovich M, Tuttle TM. Trends in the incidence and treatment of parathyroid cancer in the United States. Cancer. 2007 May 1;109(9):1736-41. doi: 10.1002/cncr.22599. PMID 17372919
- BACKGROUNDHowlett DC, Speirs A. The thyroid incidentaloma--ignore or investigate? J Ultrasound Med. 2007 Oct;26(10):1367-71. doi: 10.7863/jum.2007.26.10.1367. PMID 17901140
- DERIVEDNeychev V, Steinberg SM, Yang L, Mehta A, Nilubol N, Keil MF, Nieman L, Stratakis CA, Kebebew E. Long-Term Outcome of Bilateral Laparoscopic Adrenalectomy Measured by Disease-Specific Questionnaire in a Unique Group of Patients with Cushing's Syndrome. Ann Surg Oncol. 2015 Dec;22 Suppl 3(Suppl 3):S699-706. doi: 10.1245/s10434-015-4605-1. Epub 2015 May 13. PMID 25968622