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NCT00005927 · ClinicalTrials.gov registry record
Study of Adrenal Gland Tumors
A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- 690
- Enrollment target
NCT00005927: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00005927 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 690 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005927 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- 690 participants
- Enrollment target
Study 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 ba
Primary Outcome
-to define the germline and/or somatic genetic mutations causing ACTH-independent Cushing s syndrome -to define the biochemical functionality of mutations in adrenocortical tumor -to investigate novel therapeutic strategies to control hormone over-secretion of biochemically active adrenal tumors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2002-07-01 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00005927 record still lists
NCT00005927 is an observational study that tracks outcomes without assigning an intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00005927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005927 about?
NCT00005927 is a clinical study titled "Study of Adrenal Gland Tumors". 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, ...
What is the current status of trial NCT00005927?
This trial is currently completed. The enrollment target is 690 participants. The study started on 2002-07-01.
Who is sponsoring clinical trial NCT00005927?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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