- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03042026
Developing a Simple Recognition System of Acromegaly
Study Overview
Status
Conditions
Detailed Description
Background: Acromegaly is a slowly progressive disease caused by growth hormone (GH) excess. The estimated prevalence of the disease is 40 cases/1000000 population with 3-4 new cases/1000000 population per year. Most patients have classic manifestations due to acral and soft tissue change, including thickening of the calvarium, increased size of frontal sinus, enlargement of the nose, prognathism, and widely spaced teeth. The hands and feet are large, thickened and bulky. Acromegaly was also associated with many comorbidities including cardiovascular complications (acromegalic cardiomyopathy and arterial hypertension), respiratory complications (sleep apnea), metabolic complication (impaired glucose tolerance, diabetes mellitus), joint and bone complications (carpal-tunnel syndrome, osteoarthritis).3 The outcome of growth hormone level suppression after transsphenoidal surgery is far better for microadenomas (80-90%) than for macroadenomas (less than 50%). Furthermore, higher growth hormone level at diagnosis was related to poor prognosis. An early detection of acromegaly with early intervention was desirable. However, due to the slowly progression of the disease, times from symptom onset to diagnosis were 5.2 to 5.9 year4.
Current method to diagnose patients with acromegaly was to check serum GH and insulin-like growth factor 1 (IGF-1). However, tests for growth hormone and IGF-1 are currently unavailable in most hospitals in Taiwan and were expensive. We want to find a better screening tool for acromegaly with less expensive and high efficacy. Due to specific facial appearance of acromegaly, there were studies to recognize acromegaly by computer program1,2,3. They tried to develop computer programs to separate facial photographs of patient with acromegaly and normal subjects. The accuracy could reach 71.9% to 86%. Due to enlarged hand with increased soft tissue in patients with acromegaly, we also want to compare the difference of face, hand and feet morphology and face, hand and feet X ray of acromegaly patients with those of normal population. We hope to set a computer model to early detect acromegaly patients in Chinese people.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Shyang-Rong Shih, PhD
- Phone Number: 886-2-23123456
- Email: srshih@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Shyang-Rong Shih, PhD
- Phone Number: 2-23123456
- Email: srshih@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 20-80 years old, Acromegaly patients or Healthy Adults
Exclusion Criteria:
- Pregnancy. Age less than 20 years old or older than 80 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Acromegaly patients
|
Healthy subjects
Healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometry
Time Frame: 1 year from the first time of 3D stereophotography
|
Features of the body including face, hands and feet
|
1 year from the first time of 3D stereophotography
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shyang-Rong Shih, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201204079RIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acromegaly
-
Andrea M. IsidoriCompletedAcromegaly CardiomyopathyItaly
-
University of CopenhagenOdense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Aalborg University Hospital and other collaboratorsCompletedAcromegaly Due to Pituitary AdenomaDenmark
-
Samsung Medical CenterNot yet recruitingAcromegaly Due to Pituitary AdenomaKorea, Republic of
-
PfizerRecruiting
-
University Hospital, MontpellierRecruiting
-
Ginkgo Leaf Center for Rare DisordersRecruiting
-
Cedars-Sinai Medical CenterActive, not recruitingAcromegalyUnited States
-
Camurus ABActive, not recruitingAcromegalyUnited States, Spain, United Kingdom, Germany, Russian Federation, Greece, Hungary, Italy, Poland, Turkey, Serbia
-
Crinetics Pharmaceuticals Inc.Active, not recruitingAcromegalyUnited States, Argentina, Belgium, Brazil, Bulgaria, France, Hungary, Israel, Italy, Peru, Poland, Russian Federation, Serbia, United Kingdom
-
Crinetics Pharmaceuticals Inc.Active, not recruitingAcromegalyUnited States, Hungary, Brazil, Greece, Serbia, United Kingdom