Cushing SyndromeNCT00029952
Long Term Post Operative Follow-Up of Cushing Syndrome
An observational study of Cushing Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cushing Syndrome
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1993to Sep 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no formal exclusion criteria, if the patient meets the inclusion criteria above. All ethnic groups and both genders will be recruited. However, patients may be withdrawn from the study by the PI if they are unable to meet study requirments, such as mailing questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: 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:
- 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.
- 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.
- Do any factors in the immediate postoperative period predict who will experience a recurrence of Cushing syndrome?
- 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.
Read the 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 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
- Cushing Syndrome
- Keywords
- Cortisol, Bone Density, Cushing Syndrome, Postoperative
- Medical subject headings
- Cushing Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2002 (estimated)
- Study startJul 1993
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029952
- Sponsor's protocol ID
- 930169
- Other IDs
- 93-CH-0169
- Status last verified
- Sep 2004
- First submitted
- 26 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res. 1997 Aug;6(6):531-54. doi: 10.1023/a:1018460132567.
PubMed 9330553Ross EJ, Linch DC. Cushing's syndrome--killing disease: discriminatory value of signs and symptoms aiding early diagnosis. Lancet. 1982 Sep 18;2(8299):646-9. doi: 10.1016/s0140-6736(82)92749-0. No abstract available.
PubMed 6125785Tarlov AR, Ware JE Jr, Greenfield S, Nelson EC, Perrin E, Zubkoff M. The Medical Outcomes Study. An application of methods for monitoring the results of medical care. JAMA. 1989 Aug 18;262(7):925-30. doi: 10.1001/jama.262.7.925.
PubMed 2754793
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Post-Operative Follow-Up of Cushing Syndrome
- ClinicalTrials.gov ID
- NCT00029952
- Acronym / sponsor ID
- 930169
- Conditions
- Cushing Syndrome
- Keywords
- Cortisol, Bone Density, Cushing Syndrome, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 1993
- Study completion
- Sep 2004
- First posted
- 28 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Do any factors in the immediate postoperative period predict who will experience a recurrence of Cushing syndrome?
- 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 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients must be able to read and write in English.
Key exclusion criteria (1 listed)
- There are no formal exclusion criteria, if the patient meets the inclusion criteria above. All ethnic groups and both genders will be recruited. However, patients may be withdrawn from the study by the PI if they are unable to meet study requirments, such as mailing questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9330553Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res. 1997 Aug;6(6):531-54. doi: 10.1023/a:1018460132567.
- Background: PubMed 6125785Ross EJ, Linch DC. Cushing's syndrome--killing disease: discriminatory value of signs and symptoms aiding early diagnosis. Lancet. 1982 Sep 18;2(8299):646-9. doi: 10.1016/s0140-6736(82)92749-0. No abstract available.
- Background: PubMed 2754793Tarlov AR, Ware JE Jr, Greenfield S, Nelson EC, Perrin E, Zubkoff M. The Medical Outcomes Study. An application of methods for monitoring the results of medical care. JAMA. 1989 Aug 18;262(7):925-30. doi: 10.1001/jama.262.7.925.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.