Evaluation of Molecular Markers in Adrenal Tumors

NCT ID: NCT01348698

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-04
• Study Completion Date: 2018-01-12

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.

Conditions

Adrenal Gland Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adrenal Gland Neoplasm

To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells. Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor.

Tumor tissue biopsy

Intervention Type: PROCEDURE

Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.

Surgery

Intervention Type: PROCEDURE

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.

Interventions

Tumor tissue biopsy

Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.

Intervention Type: PROCEDURE

Surgery

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Naris Nilubol, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naris Nilubol, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8521790 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14768652 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18626702 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

11-C-0149

Identifier Type: -

Identifier Source: secondary_id

110149

Identifier Type: -

Identifier Source: org_study_id