AcromegalyNCT03042026
Developing a Simple Recognition System of Acromegaly
An observational study of Acromegaly, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2012to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acromegaly patients and Healthy Adults
Who may be able to join
- Age 20-80 years old, Acromegaly patients or Healthy Adults
Who cannot join
- Pregnancy. Age less than 20 years old or older than 80 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shyang-Rong Shih, PhD, 2-23123456, srshih@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
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 |
|---|---|---|
| Acromegaly patients | Acromegaly patients | |
| Healthy subjects | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
Features of the body including face, hands and feet
Measured: 1 year from the first time of 3D stereophotography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jun 2012
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2027 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyang-Rong Shih, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042026
- Sponsor's protocol ID
- 201204079RIC
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Simple Recognition System of Acromegaly
- ClinicalTrials.gov ID
- NCT03042026
- Acronym / sponsor ID
- 201204079RIC
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 Feb 2017 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromegaly patients | – | –Acromegaly patients |
| Healthy subjects | – | –Healthy volunteers |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acromegaly patients and Healthy Adults
Key inclusion criteria (1 listed)
- Age 20-80 years old, Acromegaly patients or Healthy Adults
Key exclusion criteria (1 listed)
- Pregnancy. Age less than 20 years old or older than 80 years old
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
Anthropometry
Time frame: 1 year from the first time of 3D stereophotography
Features of the body including face, hands and feet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Shyang-Rong Shih, PhD principal investigator
National Taiwan University Hospital
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 Acromegaly, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: looking for participants now, as of the sponsor's last update on 7 Feb 2017. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, PhD (886-2-23123456, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry (time frame: 1 year from the first time of 3D stereophotography). It is what the study was designed to measure, not a finding.
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 7 Feb 2017.