Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
18 Years
90 Years
Both
Adrenal Gland Neoplasms
Trial Information
Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
Background:
- Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal
imaging studies.
- 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.
Objectives:
- Primary Objectives:
- To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy
samples.
- 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
Eligibility:
- 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
Design:
- 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
clinical practice.
- Projected accrual will be 50 patients per year for a total of 10 years. Thus, we
anticipate accruing 500 patients on this protocol.
Inclusion Criteria
- INCLUSION CRITERIA:
1. An individual with a primary localized adrenal neoplasm greater than 2 cm in
size
2. Age greater than 18 years
3. Adults must be able to understand and sign the informed consent document
4. Patients must have an ECOG performance score of 0-2.
5. Patients must have laboratory and physical examination parameters within
acceptable limits by standard of practice guidelines prior to biopsy or surgery
Note: patients with suspected but unconfirmed adrenal neoplasm may be enrolled.
EXCLUSION CRITERIA:
1. Biochemically proven Pheochromocytoma
2. Women who are pregnant because of the possible side effects of radiation from
CT-guided biopsies to the unborn child.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy samples.
Principal Investigator
Electron Kebebew, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
110149
NCT ID:
NCT01348698
Start Date:
April 2011
Completion Date:
Related Keywords:
- Adrenal Gland Neoplasms
- Adrenal Cancer
- Pheochromocytoma
- Functioning Tumor
- Nonfunctioning Tumor
- Gene Expression
- Adrenal Tumor
- Adrenal Gland Neoplasms
- Neoplasms
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
