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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 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.

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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\>

Interventions

  • DRUG oCRH

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 1,387 participants
Start Date 1995-12-14

What the Registry Record Tells You About NCT00001452

The ClinicalTrials.gov registry entry for NCT00001452 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,387 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (927% higher). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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