Actively Recruiting

Age: 4Years +
All Genders
ID01005654

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Led by National Cancer Institute (NCI) · Updated on 2026-06-08

2415

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Endocrine tumors, including those of the thyroid, parathyroid, adrenal gland, pancreas, and other neuroendocrine tissues, are increasing rapidly in incidence and can be challenging to classify as benign or malignant. Researchers aim to study the molecular changes involved in the development and growth of these endocrine cancers. This observational study focuses on collecting samples from patients undergoing surgery or biopsy for these tumors to better understand their genetic, epigenetic, metabolomic, and proteomic profiles. Participants scheduled for surgery or biopsy of endocrine tumors will provide blood and urine samples before the procedure. During surgery, tumor or precancerous tissue and nearby normal tissue will be collected for research purposes. After surgery, participants will receive standard care and follow-up visits, including a postoperative check approximately six weeks later and yearly follow-ups either in person or by phone. Throughout the study, researchers will analyze the collected tissues and samples to develop profiles that distinguish benign from malignant tumors and study gene expression and molecular changes. Participants will be monitored for clinical outcomes and receive routine care as determined by their doctors. The total follow-up duration can extend up to 10 years to support long-term research goals.

CONDITIONS

Brief Title

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Who Can Participate

Age: 4Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with endocrine tumors or pre-malignant conditions based on radiographic, biochemical, or biopsy evidence involving thyroid, parathyroid, adrenal, pancreas, or related neuroendocrine tissues
  • Participants referred for surgical evaluation of endocrine disorders
  • Participants with an ECOG performance score of 0 to 2
  • Participants with physical exam results within acceptable limits for surgery or biopsy
  • Participants planning to undergo surgery or biopsy as part of their treatment
  • Participants aged 4 years or older
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery or biopsy

Participants undergo surgery or biopsy to obtain tissue samples of endocrine neoplasms or pre-malignant conditions as part of routine care. Blood samples are also collected during the procedure.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants are followed for up to 10 years to monitor clinical outcomes and correlate with molecular analyses of the tissue samples.

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

K

Kristine J Villaruel

N

Naris Nilubol, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Long-Term Outcome of Bilateral Laparoscopic Adrenalectomy Measured by Disease-Specific Questionnaire in a Unique Group of Patients with Cushing's Syndrome.

Vladimir Neychev, Seth M Steinberg, Lily Yang...

https://pubmed.ncbi.nlm.nih.gov/25968622