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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00005927 |
Purpose
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:
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.
| Condition |
|---|
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Adrenal Gland Neoplasm |
| Study Type: | Observational |
| Official Title: | Clinical and Molecular Analysis of ACTH-Independent Steroid Hormone Production in Adrenocortical Tissue |
| Estimated Enrollment: | 2000 |
| Study Start Date: | June 2000 |
The adrenal glands are the major source in the body of the steroid hormones. In normal physiology, the pituitary hormone ACTH regulates the secretion of glucocorticoids, while the secretion of mineralocorticoids is controlled by the renin-angiotensin system. In addition to these two steroids, the adrenal gland secretes lesser amounts of intermediate metabolites of these steroids, as well as the sex-steroids DHEA, DHEAS, androstenedione, testosterone, estrogen, and estrone. Dysregulated secretion of any of these hormones can be caused by sporadic adrenocortical adenomas or carcinomas, with the development of specific clinical syndromes depending on the identity of the hormones secreted. Similar clinical phenomena can also occur in the setting of a primary, bilateral hyperplasia of the adrenal cortex. In at least a subset of cortisol-producing adrenocortical neoplasms, the presence of ectopic or abnormal receptors has been described, resulting in the regulation of cortisol by non-physiologic stimuli. The present study will serve as a mechanism to investigate individuals with steroid hormone-secreting adrenocortical tumors of all types for the purpose of identifying hereditary, congenital, or acquired defects leading not only to hormone oversecretion, but also to tumor formation. The first goal of the study will be to examine the prevalence of ectopic receptor expression in hormone secreting adrenocortical tumors. This aim will aid in the understanding of the ontogeny of these tumors, as well as lead to the development of novel therapeutic strategies (e.g., receptor antagonists) to control hormone oversecretion. The second goal of the study will be to perform a comparative analysis of the expression of large sets of genes using the emerging technology of gene array/gene chip analysis. This study will generate important diagnostic information about the malignant potential of adrenocortical neoplasms, information which at present can only be obtained through follow-up of patients and retrospective analysis. This information may help to identify patients who would benefit from more aggressive intervention strategies. Thirdly, this study will also provide for the establishment of a bank of tissues of varying malignant potential from the adrenal cortex, which may serve in the future as an experimental resource to test new diagnostic and therapeutic methods.
Eligibility| Ages Eligible for Study: | 3 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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. This condition is meant to include the possibility of individuals with subclinical hormone secretion syndromes, which may be detectable at the biochemical level even in the absence of frank clinical signs/symptoms.
All eligible patients are invited to participate in this protocol, regardless of sex, race or ethnic origin. All populations appear at risk for adrenal tumors, and therefore the subject population can include Native Americans, Asian/Pacific Islanders, Caucasian, Hispanic, and Black individuals. Patients will be accepted for evaluation based on referral from clinicians, or may be self-referred, if they can provide evidence supportive of the diagnosis of hormone oversecretion. Patients must be willing to return to the NIH for follow-up evaluation.
Patients may withdraw from the study at any time.
B. EXCLUSION CRITERIA:
Contacts and Locations| Contact: Constantine A Stratakis, M.D. | (301) 594-5984 | stratakc@cc1.nichd.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Constantine A Stratakis, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
More Information
| ClinicalTrials.gov Identifier: | NCT00005927 History of Changes |
| Other Study ID Numbers: | 000160, 00-CH-0160 |
| Study First Received: | June 28, 2000 |
| Last Updated: | April 14, 2012 |
| Health Authority: | United States: Federal Government |
|
Adrenal Adenoma Adrenal Cancer Macronodular Adrenals Ectopic Receptors Gene Profiling Adrenocortical Carcinoma |
Cushing Syndrome Virilizing Adrenal Tumor Feminizing Adrenal Tumor Massive Macronodular Adrenocortical Disease Adrenal Gland Tumor |
|
Adrenal Gland Neoplasms Neoplasms Endocrine Gland Neoplasms |
Neoplasms by Site Adrenal Gland Diseases Endocrine System Diseases |