Recruiting

Endocrine Neoplasms

Sponsor:

National Cancer Institute (NCI)

Code:

NCT01005654

Conditions

Endocrine Tumors

Thyroid Neoplasms

Parathyroid Neoplasms

Adrenal Neoplasm

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Study Details

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 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

Endocrine Tumors

Thyroid Neoplasms

Parathyroid Neoplasms

Adrenal Neoplasm

Neuroblastoma

Study ID

NCT01005654

Start date

Oct 7, 2009

Status verified date

Jun 9, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

2415 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Participants with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy

Primary outcome 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. [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 1, 2026

Last verified

Jun 9, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-01.