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NCT00029952 · ClinicalTrials.gov registry record

Long Term Post Operative Follow-Up of Cushing Syndrome

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
500
Enrollment target

NCT00029952: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00029952 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 500 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00029952 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
500 participants
Enrollment target

Study Summary

Although most patients with hypercortisolism can be diagnosed and treated the long-term effects of hypercortisolism and its treatment are unknown. This study will attempt to answer the following questions: 1. What is the rate of perioperative complications? Patients with Cushing syndrome often undergo transsphenoidal surgery of the pituitary gland as treatment for the disease. During this surgical procedure the pituitary gland is reached by passing through the sphenoid bone. The risk for patients to develop hypopituitarism in the immediate postoperative period is unknown. Patients with Cushing syndrome have abnormal levels of hormones circulating in the blood and affects of the surgery are often not apparent until long after the procedure. 2. What is the recurrence rate? The recurrence rate of the disease has been estimated between 5 - 10%. However, these figures have not been confirmed. If the actual rate of recurrence is higher than estimated many patients may elect to undergo radiation therapy which has a lower rate of recurrence. 3. Do any factors in the immediate postoperative period predict who will experience a recurrence of Cushing syndrome? 4. What are the long-term complications of hypercortisolism? Studies have shown that patients with hypercortisolism have a four times greater risk of death than people of the same age without hypercortisolism. Researchers tend to believe this figure is too high. However, it is well established that hypercortisolism weakens bones (decreased bone density), causes secondary hypogonadism, increases levels of fat in the blood (hyperlipidemia), and decreases thyroid function (hypothyroidism). The potential for these conditions to be reversed is not known. These questions will be addressed by blood and urine sampling in the postoperative period, and by outpatient follow-up and periodic questionnaires in the first 10 years after curative surgery for Cushing syndrome performed at the NIH.

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 1993-07
Est. Completion 2004-09

What the finished NCT00029952 record still lists

NCT00029952 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00029952 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00029952 about?

NCT00029952 is a clinical study titled "Long Term Post Operative Follow-Up of Cushing Syndrome". Although most patients with hypercortisolism can be diagnosed and treated the long-term effects of hypercortisolism and its treatment are unknown. This study will attempt to answer the following questions: 1. What is the rate of perioperative complications? Patients with Cushing syndrome often unde...

What is the current status of trial NCT00029952?

This trial is currently completed. The enrollment target is 500 participants. The study started on 1993-07. Estimated completion is 2004-09.

Who is sponsoring clinical trial NCT00029952?

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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Source: ClinicalTrials.gov NCT00029952, the US trial registry maintained by the National Library of Medicine. NCT00029952 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.