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| Sponsored by: |
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 |
|---|
|
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 |
| Estimated Study Completion Date: | July 2005 |
| Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
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.
Patients must be willing to return to the NIH for follow-up evaluation.
Patients may withdraw from the study at any time.
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.
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.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 000160, 00-CH-0160 |
| Study First Received: | June 28, 2000 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005927 History of Changes |
| 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 |
|
Adrenocortical Carcinoma Cushing Syndrome Adrenal Gland Diseases Endocrine System Diseases Cardiac Complexes, Premature Hormones Carcinoma |
Adrenal Gland Neoplasms Adrenal Cancer Endocrinopathy Epinephrine Adenoma Endocrine Gland Neoplasms |
|
Neoplasms Neoplasms by Site Adrenal Gland Neoplasms |
Endocrine System Diseases Adrenal Gland Diseases Endocrine Gland Neoplasms |