Clinical trial NCT01348698: Evaluation of Molecular Markers in Adrenal Tumors
Official title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adrenal Gland Neoplasms
Keywords: Adrenal Cancer
Pheochromocytoma
Functioning Tumor
Nonfunctioning Tumor
Gene Expression
Adrenal Tumor
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-05-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous. An individual with an adrenal neoplasm greater than 2cm in size.

Brief summary: Background:

- Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are no tests that can accurately tell which adrenal tumors are cancerous and which are not. The only way to tell is to remove the tumor with surgery and then examine it. Researchers have been using new methods to study samples of adrenal tissue. These methods may help identify whether the cells are or may become cancerous without an operation. This information will help doctors determine which tumors will need to be removed.

Objectives:

- To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells.

Eligibility:

- Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous.

Design:

* Participants will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
* Participants will be examined to determine whether they have a specific type of adrenal tumor

(pheochromocytoma).

* Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for study.
* Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.
* Researchers will examine the collected tissue. They will try to determine whether the cells are cancerous or may become cancerous.
* Participants will be asked to return to the National Institutes of Health Clinical Center every year for about 5 years. During these visits they will have imaging studies, lab tests, and a physical examination.

Detailed description: 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 or equal to 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.

Eligibility criteria: * INCLUSION CRITERIA:

  1. An individual with a primary localized adrenal neoplasm greater than 2 cm in size
  2. Age greater than or equal to 18 years
  3. Adults must be able to understand and sign the informed consent document
  4. Patients must have an Eastern Cooperative Oncology Group (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 computed tomography (CT)-guided biopsies to the unborn child.

Primary outcomes:
measure: Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
timeFrame: 5 years
measure: Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
timeFrame: 5 years
Secondary outcomes:
measure: To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma
timeFrame: 5 years
measure: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
timeFrame: Date treatment consent signed to date off study, approximately 6 years and 58 days
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Naris Nilubol, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kloos RT, Gross MD, Francis IR, Korobkin M, Shapiro B. Incidentally discovered adrenal masses. Endocr Rev. 1995 Aug;16(4):460-84. doi: 10.1210/edrv-16-4-460.
citation: NIH state-of-the-science statement on management of the clinically inapparent adrenal mass ("incidentaloma"). NIH Consens State Sci Statements. 2002 Feb 4-6;19(2):1-25.
citation: Toniato A, Boschin I, Bernante P, Foletto M, Guolo AM, Pelizzo MR, Opocher G, Ballotta E, Mantero F. Factors influencing the rising rates of adrenal surgery: analysis of a 25-year experience. Surg Endosc. 2009 Mar;23(3):503-7. doi: 10.1007/s00464-008-0061-3. Epub 2008 Jul 15.