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NCT00001452 · ClinicalTrials.gov registry record
Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex
A clinical trial of Pituitary Adenoma and Cushing's Syndrome, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- 1,387
- Enrollment target
- 1
- Study location
NCT00001452: Completed study of Pituitary Adenoma and Cushing's Syndrome, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00001452 is a study of Pituitary Adenoma and Cushing's Syndrome that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,387 participants, above the 135-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (927% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001452, a study of Pituitary Adenoma and Cushing's Syndrome, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- 1,387 participants
- Enrollment target
- 1
- Study location
Study Summary
Lentiginosis refers to groups of diseases marked by the presence of pigmented spots on the skin. These conditions are most commonly associated with multiple tumors and changes in hormone producing glands. The cause of these diseases is unknown, but researchers suggest there may be a level of inheritance involved in their development. Meaning to say that some of these diseases may "run in the family" and be passed down form generation to generation. Primary pigmented nodular adrenocortical disease (PPNAD) is a pituitary-independent, primary adrenal form of hypercortisolism characterized by; 1. Resistance to suppression by the drug dexamethasone 2. The body is unable to secrete cortisol in a normal rhythm 3. Distinct microscopic changes of both adrenal glands PPNAD can be associated with tumors (myxomas) of the skin, heart, breast, tumors (swannomas) of the nerve sheaths, pigmented spots (nevi and lentigines) of the skin, growth hormone (GH) producing tumors of the pituitary gland, and tumors of the testicles, ovaries, and thyroid gland. In the presence of these associations the condition is referred to as the Carney Complex. Presently there are no tests for screening of PPNAD and the Carney Complex. In addition, it is unknown how these conditions are genetically transferred from generation to generation. This study proposes to use standard methods of clinical testing for endocrine and nonendocrine diseases and genetic testing in order to; 1. Define the genetic basis for PPNAD and/or the Carney Complex. 2. Determine the molecular changes associated with the development of the tumors. 3. Identify carriers of the disease. 4. Determine the prognosis for carriers and affected individuals. 5. Provide sufficient data for genetic counseling of families with PPNAD and/or Carney Complex.\<TAB\>
Primary Outcome
Genotype and clinical phenotype correlation in patients with PPNAD, Carney Complex, Peutz-Jeghers Syndrome and related conditions.
Conditions Studied
Interventions
- DRUG oCRH
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,387 participants |
| Start Date | 1995-12-14 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00001452 record still lists
NCT00001452 is an observational study that tracks outcomes without assigning an intervention. Its 1,387 participants enrollment target places it among the larger protocols in the corpus, above the 135-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (927% higher).
The record links to 5 conditions, with Pituitary Adenoma appearing as the primary indexed condition, and to 1 intervention - of which oCRH is the first listed.
NCT00001452 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001452 about?
NCT00001452 is a clinical study titled "Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex". Lentiginosis refers to groups of diseases marked by the presence of pigmented spots on the skin. These conditions are most commonly associated with multiple tumors and changes in hormone producing glands. The cause of these diseases is unknown, but researchers suggest there may be a level of inherit...
What is the current status of trial NCT00001452?
This trial is currently completed. The enrollment target is 1,387 participants. The study started on 1995-12-14.
What conditions does trial NCT00001452 study?
This clinical trial studies the following conditions: Pituitary Adenoma, Cushing's Syndrome, Carney Complex, Primary Pigmented Nodular Adrenocortical Disease, Peutz-Jeghers Syndrome.
What interventions are being tested in trial NCT00001452?
The interventions under investigation include: oCRH (DRUG).
Who is sponsoring clinical trial NCT00001452?
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.
Where is trial NCT00001452 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001452's enrollment target sits among peer trials
1,387 1st of 9 higher than 9 of 9 other Pituitary Adenoma trials
participants (enrollment target), bucketed by value
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