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Evaluation of Molecular Markers in Adrenal Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01348698
First received: May 4, 2011
Last updated: November 11, 2014
Last verified: October 2014
  Purpose

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....

Condition
Adrenal Gland Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Determine feasibility of molecular testin in adrenal neoplasm FNA samples. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2011
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 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348698

Contacts
Contact: Candice M Cottle-Delisle, R.N. (301) 402-4395 cottlec@mail.nih.gov
Contact: Electron Kebebew, M.D. (301) 496-5049 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kaitlyn Chambers    301-402-4395    kaitlyn.chambers@nih.gov   
Contact: Roxanne Merkel    (301) 402-4395    merkelre@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01348698     History of Changes
Other Study ID Numbers: 110149, 11-C-0149
Study First Received: May 4, 2011
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adrenal Cancer
Pheochromocytoma
Functioning Tumor
Nonfunctioning Tumor
Gene Expression
Adrenal Tumor

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Neoplasms
Adrenal Gland Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014