AcromegalyNCT00638287
Inter-Assay Growth Hormone and IGF-I Variability
An observational study of Acromegaly and Growth Hormone Deficiency, run by Cedars-Sinai Medical Center.
Trial summary
The purpose of this study is to demonstrate the degree of variability in commercially available assays for Growth Hormone measurement in the context of clinical decision making for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I inter-assay samples obtained at the time of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acromegaly, Growth Hormone Deficiency
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary referral center
Who may be able to join
- Male or Female age 18+
- Clinical indication for testing GH response to secretagogue testing to evaluate for GHD OR clinical indication for testing for GH response to oral glucose load (75grams of glucose) to evaluate for Acromegaly either for diagnosis OR normal volunteer for control group.
- Normal volunteers will be screened for evidence of pituitary endocrine dysfunction prior to Oral Glucose Tolerance Testing (OGTT) and Growth Hormone Releasing Hormone - Arginine Testing (GHRH-ARG).
- Able to provide informed consent
Who cannot join
- Subjects taking GH
- Pregnant or breast feeding
About this study
The purpose of this study is to demonstrate the degree of variability in commercially available assays for Growth Hormone measurement in the context of clinical decision making for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing and Oral Glucose Tolerance Testing.
Read the detailed description
This research will explore the variability of GH and IGF-1 measurements by commercially available tests. The hypothesis is that the variability in GH and IGF-1 measurement will be sizable enough that different conclusions would be drawn in patient case decision making in the diagnosis and management of GH deficiency and acromegaly.
In order to correctly diagnose disorders of growth hormone secretion, either deficiency or excess, it is necessary to have the accurate measurement of GH (growth hormone) serum and Insulin-like growth factor (IGF-1).
For this study, subjects will be asked to give the Investigators additional blood during either an OGTT (a test for acromegaly) or a growth hormone stimulation test (GHRH-arginine stimulation). Ordinarily, blood would be measured at the beginning and end of the OGTT, and for the GHRH-arginine it would be measured one half hour before the test and then every half hour for 2 hours.
For this study, subjects will provide us with additional blood at the times when blood is drawn for the clinically-indicated tests. No additional needle sticks will be necessary and taking the additional blood will not interfere with the clinical test.
The test we will be doing with the additional blood will be identical to the tests we ordinarily do, but will be done by a different lab. We are testing to see if these results would be the same as our usual lab.
The study population will include 1) subjects with pituitary disease undergoing testing for GH deficiency (GHRH arginine stimulation test), 2) subjects with suspicion of acromegaly undergoing the oral glucose tolerance test (oGTT), and 3) normal controls undergoing both the GHRH Arginine test and the oGTT. Patients from all groups will have their blood drawn for the measurement of IGF-1. The serum from each test will be aliquoted and sent to the designated labs.
For subject groups 1 and 2, this study poses no more than minimal risk, as it involves procedures that do not go beyond clinical care. For healthy controls, we know that participants will be asked to undergo testing that would not normally be required, and therefore feel that the study poses more than minimal risk.
For the primary endpoint research samples will be compared to samples sent to the usual clinical lab, and diagnoses made based on research samples will be compared to clinical samples.
For secondary endpoints, each result from a commercially available assay will be correlated to another corresponding method of analysis of the same hormone from the same time point by using the Bland-Altman analysis wherein the difference between two methods is compared to the mean of the two methods. Each sample will be compared to the sample used for clinical evaluation.
Information from the medical records will be obtained and correlated with the lab test results.
- Conditions
- Acromegaly, Growth Hormone Deficiency
- Keywords
- Subjects with pituitary disease undergoing testing for GH, deficiency, Subjects with suspicion for (or diagnosis of) acromegaly, undergoing OGTT testing, Normal controls without evidence of pituitary dysfunction
- Medical subject headings
- Acromegaly, Dwarfism, Pituitary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startNov 2007
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- John Carmichael, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638287
- Sponsor's protocol ID
- 10638
- Status last verified
- Sep 2008
- First submitted
- 11 Jan 2008
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Assay Growth Hormone and IGF-I Variability
- ClinicalTrials.gov ID
- NCT00638287
- Acronym / sponsor ID
- 10638
- Conditions
- Acromegaly, Growth Hormone Deficiency
- Keywords
- Subjects with pituitary disease undergoing testing for GH, deficiency, Subjects with suspicion for (or diagnosis of) acromegaly, undergoing OGTT testing, Normal controls without evidence of pituitary dysfunction
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Jan 2011 (estimated)
- First posted
- 19 Mar 2008 (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.
The purpose of this study is to demonstrate the degree of variability in commercially available assays for Growth Hormone measurement in the context of clinical decision making for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing and Oral Glucose Tolerance Testing.
Detailed description
This research will explore the variability of GH and IGF-1 measurements by commercially available tests. The hypothesis is that the variability in GH and IGF-1 measurement will be sizable enough that different conclusions would be drawn in patient case decision making in the diagnosis and management of GH deficiency and acromegaly.
In order to correctly diagnose disorders of growth hormone secretion, either deficiency or excess, it is necessary to have the accurate measurement of GH (growth hormone) serum and Insulin-like growth factor (IGF-1).
For this study, subjects will be asked to give the Investigators additional blood during either an OGTT (a test for acromegaly) or a growth hormone stimulation test (GHRH-arginine stimulation). Ordinarily, blood would be measured at the beginning and end of the OGTT, and for the GHRH-arginine it would be measured one half hour before the test and then every half hour for 2 hours.
For this study, subjects will provide us with additional blood at the times when blood is drawn for the clinically-indicated tests. No additional needle sticks will be necessary and taking the additional blood will not interfere with the clinical test.
The test we will be doing with the additional blood will be identical to the tests we ordinarily do, but will be done by a different lab. We are testing to see if these results would be the same as our usual lab.
The study population will include 1) subjects with pituitary disease undergoing testing for GH deficiency (GHRH arginine stimulation test), 2) subjects with suspicion of acromegaly undergoing the oral glucose tolerance test (oGTT), and 3) normal controls undergoing both the GHRH Arginine test and the oGTT. Patients from all groups will have their blood drawn for the measurement of IGF-1. The serum from each test will be aliquoted and sent to the designated labs.
For subject groups 1 and 2, this study poses no more than minimal risk, as it involves procedures that do not go beyond clinical care. For healthy controls, we know that participants will be asked to undergo testing that would not normally be required, and therefore feel that the study poses more than minimal risk.
For the primary endpoint research samples will be compared to samples sent to the usual clinical lab, and diagnoses made based on research samples will be compared to clinical samples.
For secondary endpoints, each result from a commercially available assay will be correlated to another corresponding method of analysis of the same hormone from the same time point by using the Bland-Altman analysis wherein the difference between two methods is compared to the mean of the two methods. Each sample will be compared to the sample used for clinical evaluation.
Information from the medical records will be obtained and correlated with the lab test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary referral center
Key inclusion criteria (4 listed)
- Male or Female age 18+
- Clinical indication for testing GH response to secretagogue testing to evaluate for GHD OR clinical indication for testing for GH response to oral glucose load (75grams of glucose) to evaluate for Acromegaly either for diagnosis OR normal volunteer for control group.
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Subjects taking GH
- Pregnant or breast feeding
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2008.
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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.
John Carmichael, MD principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Growth Hormone Deficiency, run by Cedars-Sinai Medical Center.
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 2 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: withdrawn, as of the sponsor's last update on 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 6 Oct 2008.