Evaluation of Molecular Markers in Adrenal Tumors

NCT01348698 | Terminated Results

• 2 other identifiers: 11014911-C-0149
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Gland Neoplasms

Keywords

Adrenal Cancer; Pheochromocytoma; Functioning Tumor; Nonfunctioning Tumor; Gene Expression; Adrenal Tumor

Outcome Measures

Primary Outcomes (2)

• Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples

  Feasibility of molecular testing in adrenal neoplasm fine needle aspiration (FNA) samples was determined by immunohistochemistry. Ribonucleic acid and deoxyribonucleic acid was extracted from fine needle aspiration and tumor tissue samples to differentiate between normal and abnormal tissue.

  5 years

• Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples

  Tumor tissue obtained via FNA and surgical resection were to be analyzed for molecular markers to help determine if cells were cancerous or may become cancerous.

  5 years

Secondary Outcomes (2)

• To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma

  5 years

• Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 6 years and 58 days

Study Arms (1)

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.

Procedure: Tumor tissue biopsy; Procedure: Surgery

Interventions

Tumor tissue biopsy PROCEDURE

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

Adrenal Gland Neoplasm

Surgery 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.

Adrenal Gland Neoplasm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• An individual with a primary localized adrenal neoplasm greater than 2 cm in size
• Age greater than or equal to 18 years
• Adults must be able to understand and sign the informed consent document
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
• 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.

You may not qualify if:

• Biochemically proven Pheochromocytoma
• Women who are pregnant because of the possible side effects of radiation from computed tomography (CT)-guided biopsies to the unborn child.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8521790 BACKGROUND

• 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.

  PMID: 14768652 BACKGROUND

• 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.

  PMID: 18626702 RESULT

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Pheochromocytoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Dr. Naris Nilubol
• Organization: National Cancer Institute

niluboln@nih.gov

301-451-2355

Study Officials

• Naris Nilubol, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: May 4, 2011
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)