Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029952
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-01-26
Brief Title:
Long Term Post Operative Follow-Up of Cushing Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Post-Operative Follow-Up of Cushing Syndrome
Status:
COMPLETED
Status Verified Date:
2004-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 Cushings syndrome 2 Do any factors in the immediate postoperative period predict recurrence of Cushings 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 Cushings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-CH-0169 | None | None | None |