NIH Clinical Research Studies

Protocol Number: 00-CH-0160

Active Accrual, Protocols Recruiting New Patients

Title:
Clinical and Molecular Analysis of ACTH-Independent Steroid Hormone Production in Adrenocortical Tissue
Number:
00-CH-0160
Summary:
The adrenal glands, located atop the kidneys, normally produce several types of hormones. Tumors of these glands may or may not secrete hormones. It is not known what causes these tumors or why some secrete hormones and others do not. Some of the tumors are benign and confined to the adrenal gland, and others are malignant (cancerous), and can spread to other parts of the body. This study will investigate how adrenal gland tumors develop, why some secrete steroid hormones and others do not, and why some are benign and others malignant.

Patients between 3 and 70 years old with a known or suspected adrenal gland tumor may be eligible for this study. Participants will be hospitalized for 7 to 10 days for various tests and procedures that may include the following:

1. Medical history and physical examination, including body measurements, as appropriate. Children and adolescents will have Tanner staging, including examination of the genitals, to determine the extent of sexual maturity.

2. 24-hour urine collection to measure hormones in the urine.

3. Imaging studies, including magnetic resonance imaging (MRI) of the brain, computed tomography (CT) and other X-ray studies.

4. Blood tests to see if the tumor secretes hormones in response to specific stimuli, including exercise, food, and various hormones. The hormones are given through an intravenous catheter, or IV-a thin plastic tube inserted into an arm vein. After the stimulus, blood is drawn through the same IV every 30 minutes for up to 3 hours to measure hormone levels. Based on the results of these tests, some patients may have additional blood tests to check hormone response to special foods, an IV salt solution, or other hormones or drugs given either IV or by mouth (in pill form).

5. Photographs to document the effects on the body of abnormal hormone secretion from the adrenal tumor.

6. Small samples of blood and tumor tissue for research and DNA (genetic) analysis.

A discussion of treatment options will be based on the results of tests. If surgery to remove the tumor is recommended, the procedure can be done at NIH under this study protocol. If a malignant tumor is found that cannot be treated surgically, chemotherapy or radiation therapy may be recommended. These options are not offered under this protocol, but may be available under a different NIH study (for example, at the National Cancer Institute). Referrals will be made at the patient's request.

Patients who had surgery may be followed at the NIH outpatient clinic for 1 year after surgery. Patients with certain types of tumors may continue to be followed at NIH once a year for up to 5 years.

A registry of study participants will be created to keep records and correlate medical histories with tissues kept at NIH. The registry will also be used to inform participants of research studies they may be interested in. No individuals or organizations outside of NIH will have access to the registry.

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patients are adults or children with evidence for the existence of a tumor of the adrenal glands, as indicated by previously obtained imaging studies and/or biochemical investigation of hormonal secretion.

Patients must be willing to return to the NIH for follow-up evaluation.

Patients may withdraw from the study at any time.

EXCLUSION CRITERIA:

Children less than 3 years old will be excluded.

Individuals over the age of 70 years of age will be excluded.

Individuals whose medical status will not allow them, for safety reasons, to participate in the provocative testing or who have unacceptably high risk for surgical morbidity and mortality will be excluded.

Individuals found to have a known inherited syndrome as the cause for hormone oversecretion will be excluded.

Specific examples of syndromes to may be excluded from this protocol include individuals with Carney Complex, McCune-Albright syndrome, and MEN-1.

Individuals with a diagnosis of glucocorticoid-remediable aldosteronism (GRA) are excluded from participation in this protocol.

For family members studied for linkage analysis, the following criteria must be met:

These individuals can be of any age. Each must be a member of a kindred suspected of having an inherited form of adrenal neoplasia, as evidenced by results of a patient studied under above eligibility criteria.

Special Instructions: Currently Not Provided
Keywords:
Adrenal Adenoma
Adrenal Cancer
Macronodular Adrenals
Ectopic Receptors
Gene Profiling
Adrenocortical Carcinoma
Cushing Syndrome
Virilizing Adrenal Tumor
Feminizing Adrenal Tumor
Massive Macronodular Adrenocortical Disease
Recruitment Keywords:
Adrenal Gland Tumor
Conditions:
Adrenal Gland Neoplasm
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Glucocorticoid-Remediable Aldosteronism

Hyper- and hypoaldosteronism

Familial hyperaldosteronism type II: description of a large kindred and exclusion of the aldosterone synthase

Active Accrual, Protocols Recruiting New Patients

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