Cushing's SyndromeNCT00361777
Diagnostic Performance of Screening Tests for Cushing s Syndrome
An observational study of Cushing's Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
This study will test the accuracy of screening tests for Cushing s syndrome in overweight people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess production of the hormone cortisol. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cushing's Syndrome
- How many people
- 471 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2002to 30 Oct 2019
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for weight loss treatment at the GWUWMP
- Patients must have at least two of the signs and symptoms in Table 1 of the protocol, in addition to weight gain. If abdominal pain, backache and/or headache are present, only one of these symptoms can be used in any given patient, so that another feature must be present.
- Willing and able to be seen for up to 24 months
- Age 18-75
Who cannot join
- Weight more than 350 pounds, the maximum weight for radiologist examination tables necessary for the evaluation of Cushing's Syndrome
- Renal failure, creatinine greater than 2.6, because of possible effects on dexamethasone metabolism
- Pregnancy, because it alters interpretation of adrenal function tests
- Current use of oral, inhaled or intranasal glucocorticoids or use within 30 days of study
- Other significant medical disorders that may complicate participation or interpretation of the results. For example, a patient with a collagen vascular disorder who has taken intermittent high dose glucocorticoids, and might need to do this again, might not be offered participation.
- Use of black licorice or chewing tobacco within two weeks of the study or anticipated use during the study
- Use of phenytoin, barbiturate, loperamide or opiates within two weeks of the study or anticipated chronic use during the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
GW University Medical Center GW Hospital Center
Washington D.C., District of Columbia, 20037
About this study
Official title: The Diagnostic Performance of Screening Tests for the Diagnosis of Cushing's Syndrome
This study will test the accuracy of screening tests for Cushing s syndrome in overweight people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess production of the hormone cortisol. Patients may have various problems, such as weight gain, high blood pressure, diabetes, infections, mood problems, trouble concentrating, and increased blood clotting. These symptoms are seen in many other disorders as well, complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s syndrome is not known. To test their accuracy, subjects in this study who test positive for Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the laboratory results.
Patients between 18 and 75 years of age who are being treated at the George Washington University Weight Management Program (GWUWMP) may participate in this study. Candidates will be screened with a medical history, physical examination, measurement of body fat, blood tests, and oral glucose tolerance test. They will also complete a symptoms checklist and quality of life questionnaire.
Read more
Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens blood, saliva, and urine will be tested for cortisol levels.
People whose test results are abnormal will be seen at the NIH outpatient clinic for a medical history, physical examination, and blood tests; bedtime saliva collection; two 24-hour urine collections; and a 2-day 2-mg DST, followed by administration of corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the 2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels and after giving CRH to measure cortisol levels.
People whose test results are normal will not be seen further at NIH. Those with high cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24 months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose increased cortisol is found to be due to another condition besides Cushing s syndrome will be referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will have standard tests to identify the tumor causing the disorder, followed by standard medical and surgical treatment.
Read the detailed description
Cushing's syndrome is a rare disorder characterized by a variety of clinical signs and symptoms that reflect chronic exposure to hypercortisolism such as obesity, hypertension, glucose intolerance, infections, psychiatric disturbance, impaired cognition and hypercoagulability. Thus, it is important to screen for this treatable disorder so as to prevent its associated morbidity and mortality. Because many of the signs of Cushing's syndrome are common in the general population, information about the cost-effectiveness and diagnostic efficiency of various screening tests would be useful.
This study will evaluate the diagnostic performance of various screening tests for Cushing's syndrome in overweight patients recruited from a weight loss center who have additional signs of the disorder. Patients with abnormal tests will be seen as outpatients at the NIH for further evaluation for up to two years to confirm or refute the possibility that they have Cushing's syndrome. Patients with the disorder will be treated.
- Conditions
- Cushing's Syndrome
- Keywords
- Dexamethasone, Cushing Syndrome
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Possible Cushing's | Patients with possible cushion's syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of screening tests
Sensitivity and specificity of screening tests
Measured: months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study start19 Sep 2002
- Study completion30 Oct 2019
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's 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361777
- Sponsor's protocol ID
- 020309
- Other IDs
- 02-CH-0309
- Status last verified
- 30 Oct 2019
- First submitted
- 8 Aug 2006
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Castro M, Elias PC, Quidute AR, Halah FP, Moreira AC. Out-patient screening for Cushing's syndrome: the sensitivity of the combination of circadian rhythm and overnight dexamethasone suppression salivary cortisol tests. J Clin Endocrinol Metab. 1999 Mar;84(3):878-82. doi: 10.1210/jcem.84.3.5521.
PubMed 10084565Crapo L. Cushing's syndrome: a review of diagnostic tests. Metabolism. 1979 Sep;28(9):955-77. doi: 10.1016/0026-0495(79)90097-0.
PubMed 225638Gold PW, Loriaux DL, Roy A, Kling MA, Calabrese JR, Kellner CH, Nieman LK, Post RM, Pickar D, Gallucci W, et al. Responses to corticotropin-releasing hormone in the hypercortisolism of depression and Cushing's disease. Pathophysiologic and diagnostic implications. N Engl J Med. 1986 May 22;314(21):1329-35. doi: 10.1056/NEJM198605223142101.
PubMed 3010108
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Performance of Screening Tests for the Diagnosis of Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT00361777
- Acronym / sponsor ID
- 020309
- Conditions
- Cushing's Syndrome
- Keywords
- Dexamethasone, Cushing Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 19 Sep 2002
- Study completion
- 30 Oct 2019
- First posted
- 9 Aug 2006 (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.
This study will test the accuracy of screening tests for Cushing s syndrome in overweight people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess production of the hormone cortisol. Patients may have various problems, such as weight gain, high blood pressure, diabetes, infections, mood problems, trouble concentrating, and increased blood clotting. These symptoms are seen in many other disorders as well, complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s syndrome is not known. To test their accuracy, subjects in this study who test positive for Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the laboratory results.
Patients between 18 and 75 years of age who are being treated at the George Washington University Weight Management Program (GWUWMP) may participate in this study. Candidates will be screened with a medical history, physical examination, measurement of body fat, blood tests, and oral glucose tolerance test. They will also complete a symptoms checklist and quality of life questionnaire.
Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens blood, saliva, and urine will be tested for cortisol levels.
People whose test results are abnormal will be seen at the NIH outpatient clinic for a medical history, physical examination, and blood tests; bedtime saliva collection; two 24-hour urine collections; and a 2-day 2-mg DST, followed by administration of corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the 2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels and after giving CRH to measure cortisol levels.
People whose test results are normal will not be seen further at NIH. Those with high cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24 months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose increased cortisol is found to be due to another condition besides Cushing s syndrome will be referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will have standard tests to identify the tumor causing the disorder, followed by standard medical and surgical treatment.
Detailed description
Cushing's syndrome is a rare disorder characterized by a variety of clinical signs and symptoms that reflect chronic exposure to hypercortisolism such as obesity, hypertension, glucose intolerance, infections, psychiatric disturbance, impaired cognition and hypercoagulability. Thus, it is important to screen for this treatable disorder so as to prevent its associated morbidity and mortality. Because many of the signs of Cushing's syndrome are common in the general population, information about the cost-effectiveness and diagnostic efficiency of various screening tests would be useful.
This study will evaluate the diagnostic performance of various screening tests for Cushing's syndrome in overweight patients recruited from a weight loss center who have additional signs of the disorder. Patients with abnormal tests will be seen as outpatients at the NIH for further evaluation for up to two years to confirm or refute the possibility that they have Cushing's syndrome. Patients with the disorder will be treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Possible Cushing's | – | –Patients with possible cushion's syndrome |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting for weight loss treatment at the GWUWMP
- Patients must have at least two of the signs and symptoms in Table 1 of the protocol, in addition to weight gain. If abdominal pain, backache and/or headache are present, only one of these symptoms can be used in any given patient, so that another feature must be present.
- Willing and able to be seen for up to 24 months
- Age 18-75
Key exclusion criteria (7 listed)
- Weight more than 350 pounds, the maximum weight for radiologist examination tables necessary for the evaluation of Cushing's Syndrome
- Renal failure, creatinine greater than 2.6, because of possible effects on dexamethasone metabolism
- Pregnancy, because it alters interpretation of adrenal function tests
- Current use of oral, inhaled or intranasal glucocorticoids or use within 30 days of study
- Other significant medical disorders that may complicate participation or interpretation of the results. For example, a patient with a collagen vascular disorder who has taken intermittent high dose glucocorticoids, and might need to do this again, might not be offered participation.
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
Sensitivity and specificity of screening tests
Time frame: months
Sensitivity and specificity of screening tests
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 16 Dec 2019.
- Background: PubMed 10084565Castro M, Elias PC, Quidute AR, Halah FP, Moreira AC. Out-patient screening for Cushing's syndrome: the sensitivity of the combination of circadian rhythm and overnight dexamethasone suppression salivary cortisol tests. J Clin Endocrinol Metab. 1999 Mar;84(3):878-82. doi: 10.1210/jcem.84.3.5521.
- Background: PubMed 225638Crapo L. Cushing's syndrome: a review of diagnostic tests. Metabolism. 1979 Sep;28(9):955-77. doi: 10.1016/0026-0495(79)90097-0.
- Background: PubMed 3010108Gold PW, Loriaux DL, Roy A, Kling MA, Calabrese JR, Kellner CH, Nieman LK, Post RM, Pickar D, Gallucci W, et al. Responses to corticotropin-releasing hormone in the hypercortisolism of depression and Cushing's disease. Pathophysiologic and diagnostic implications. N Engl J Med. 1986 May 22;314(21):1329-35. doi: 10.1056/NEJM198605223142101.
Related trials for Cushing's Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
RecruitingObservational study
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Cushing's Disease, Cushing Syndrome
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.
Lynnette K Nieman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing's Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites 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 4 inclusion and 7 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Sensitivity and specificity of screening tests (time frame: months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361777, 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 16 Dec 2019.