Long Term Post Operative Follow-Up of Cushing Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-07-31

Study Completion Date

2004-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-Term Follow-Up of Survivors of Pediatric Cushing Disease

NCT03831958

Cushing Disease

RECRUITING

A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia

NCT00796783

Cushing's Syndrome

TERMINATED

Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome

NCT00004343

Cushing's Syndrome

UNKNOWN

Study of Depression, Peptides, and Steroids in Cushing's Syndrome

NCT00004334

Cushing's Syndrome

UNKNOWN

Cushing's Disease Complications

NCT02568982

Cushing's Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although most patients with hypercortisolism now can be diagnosed correctly and successfully treated, the long-term sequelae of hypercortisolism and its treatment are unknown. This study addresses the following questions: 1) What is the recurrence rate after successful treatment of Cushing's syndrome? 2) Do any factors in the immediate postoperative period predict recurrence of Cushing's syndrome? 3) What are the long-term complications of hypercortisolism in terms of mortality, morbidity, return of endocrine function and bone density? and 4) What is the quality of life for patients after surgical treatment of Cushing's syndrome? While most of these questions relate specifically to the care of patients with Cushing syndrome, the final question has relevance to the many patients rendered Cushingoid by the therapeutic use of glucocorticoids. These questions will be addressed by blood and urine sampling in the post-operative period, and by outpatient follow-up and periodic questionnaires in the first 20 years after curative surgery for Cushing syndrome performed at the NIH.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cushing Syndrome

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients with Cushing syndrome documented at the NIH will be recruited into this protocol prior to surgery intended to cure Cushing syndrome selectively. Thus, patients undergoing transsphenoidal exploration for resection of an adenoma, or unilateral adrenalectomy for an adenoma, or resection of a tumor producing ACTH ectopically will be candidates for this study. We will also recruit as many of the 500 patients treated since 1983 as possible, so as to have a group of "late follow-up" patients. These individuals will participate primarily by questionnaire.

Hematocrit about 30%. A CBC will be obtained prior to entering the study. Patients with hematocrit above 30% will be accepted into the study; iron replacement will be given to those patients with low TIBC.

Ages 18 - 85. Children less than 18 are being studied under other protocols and the questionnaire has not been validated for younger individuals.

For the questionnaire portion of the protocol there is an additional inclusion criterion:

Patients must be able to read and write in English.

Eligible Sex

ALL

Accepts Healthy Volunteers

No