Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
- Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal
- The majority of adrenal incidentalomas are cortical adenoma.
- Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to
exclude a cancer diagnosis.
- There are no reliable clinical, radiographic or laboratory studies that accurately
distinguish between localized benign and malignant adrenal neoplasm.
- This protocol is designed to determine the feasibility and accuracy of using novel
molecular markers of malignant adrenal neoplasm in fine needle aspiration (FNA) biopsy
and surgically resected samples.
- Primary Objectives:
- To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy
- To determine the accuracy of novel diagnostic molecular markers in clinical
adrenal FNA biopsy and surgically resected samples.
- Secondary Objectives:
- To analyze the gene expression level relative to disease-free survival and overall
survival in patients with adrenocortical carcinoma
- An individual with an adrenal neoplasm greater than 2cm in size
- Age greater than 18 years
- Adults must be able to understand and sign the informed consent document
- Prospective observational study.
- Demographic, clinical, laboratory and pathologic data will be collected for each
patient participant. Data will be securely stored in a computerized database.
- Patients will have biochemical testing to determine if their adrenal neoplasm is
functioning or nonfunctioning.
- After their initial on-study evaluation, patients who are found to have a
nonfunctioning adrenal tumor with a low risk of malignancy will be re-screened every
year for 5 years with non-invasive imaging studies.
- Treatment of patients with an adrenal neoplasm will be performed based on standard
- Projected accrual will be 50 patients per year for a total of 10 years. Thus, we
anticipate accruing 500 patients on this protocol.
Time Perspective: Prospective
To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy samples.
Electron Kebebew, M.D.
National Cancer Institute (NCI)
United States: Federal Government
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