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Evaluation of Molecular Markers in Adrenal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01348698
Recruitment Status : Terminated (Slow/insufficient accrual)
First Posted : May 5, 2011
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment
Adrenal Gland Neoplasms Procedure: Tumor tissue biopsy Procedure: Surgery

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.

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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
Actual Study Start Date : May 4, 2011
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018


Group/Cohort Intervention/treatment
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
Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.

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.




Primary Outcome Measures :
  1. Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples [ Time Frame: 5 years ]
    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.

  2. Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma [ Time Frame: 5 years ]
    Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.

  2. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [ Time Frame: Date treatment consent signed to date off study, approximately 6 years and 58 days ]
    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348698


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Naris Nilubol, M.D. National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC):
Publications of Results:
Other Publications:
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Responsible Party: Naris Nilubol, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01348698    
Other Study ID Numbers: 110149
11-C-0149
First Posted: May 5, 2011    Key Record Dates
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC):
Adrenal Cancer
Pheochromocytoma
Functioning Tumor
Nonfunctioning Tumor
Gene Expression
Adrenal Tumor
Additional relevant MeSH terms:
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Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases