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Developing a Simple Recognition System of Acromegaly

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ClinicalTrials.gov Identifier: NCT03042026
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
We will compare the features of 3D stereophotography of acromegaly patients with that of healthy people. We hope to develop a computerized model to help screening acromegaly patients for early detection and treatment.

Condition or disease
Acromegaly

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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Developing a Simple Recognition System of Acromegaly
Actual Study Start Date : June 1, 2012
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Acromegaly patients
Acromegaly patients
Healthy subjects
Healthy volunteers


Outcome Measures
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Primary Outcome Measures :
  1. Anthropometry [ Time Frame: 1 year from the first time of 3D stereophotography ]
    Features of the body including face, hands and feet


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Acromegaly patients and Healthy Adults
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042026


Contacts
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Contact: Shyang-Rong Shih, PhD 886-2-23123456 srshih@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shyang-Rong Shih, PhD    2-23123456    srshih@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Shyang-Rong Shih, PhD National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03042026    
Other Study ID Numbers: 201204079RIC
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases