Clinical Trial: Evaluation of Molecular Markers in Adrenal Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm

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

    Detailed Summary:

    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
      Sponsor: National Cancer Institute (NCI)

      Current Primary Outcome: Determine feasibility of molecular testin in adrenal neoplasm FNA samples. [ Time Frame: 10 Years ]

      Original Primary Outcome:

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: National Institutes of Health Clinical Center (CC)

      Dates:
      Date Received: May 4, 2011
      Date Started: April 18, 2011
      Date Completion:
      Last Updated: April 21, 2017
      Last Verified: September 28, 2016