Analysis of molecular changes in endocrine tumors
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
This study is trying to understand the differences between benign and cancerous endocrine tumors by looking at tissue samples from patients having surgery or biopsy, to help improve how these tumors are detected and treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2415 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01005654 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze tumor specimens and healthy tissue from patients scheduled for surgery or biopsy of endocrine tumors, including those in the thyroid, parathyroid, adrenal gland, and pancreas. Researchers will focus on understanding the genetic, epigenetic, metabolomic, and proteomic profiles of these tumors to better distinguish between benign and malignant forms. The study seeks to improve detection and treatment options for endocrine neoplasms by identifying diagnostic and predictive markers. Participants will be evaluated based on specific inclusion criteria related to their tumor status and overall health.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed endocrine neoplasms who are scheduled for surgical intervention or biopsy.
Not a fit: Patients without endocrine tumors or those not requiring surgery or biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for patients with endocrine tumors.
How similar studies have performed: Other studies have shown promise in analyzing molecular changes in tumors, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Naris Nilubol, M.D. — National Cancer Institute (NCI)
- Study coordinator: Kristine J Villaruel
- Email: ncieobinquiry@mail.nih.gov
- Phone: (240) 858-7033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.