Infantile HemangiomaIHNCT03173352
A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China
An observational study of Infantile Hemangioma and Capillary Hemangioma, run by Zhujiang Hospital at 1 site in China.
Trial summary
Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Hemangioma, Capillary Hemangioma, Capillary Hemangiomas
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2017
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants from the selected community
Who may be able to join
- Chinese
- The infants within 12 months of age
Who cannot join
- Those whoes guardian does not want his data to be collected in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510515
Xiaojian XJ Yo, MBBS, +8613631344241, yaoxiaojian321@163.com
Xiaojian XJ Yao, MBBS
About this study
Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, the investigators designed the study for the following purposes: 1, to aware the incidence of infantile hemangioma and understand the related risk factorsin China; 2, to understand the clinical characteristics of infantile hemangioma and the risk factors for complications; 3, to investigate the level of knowledge, treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of infantile hemangioma in parents and provide more advice for pregnancy counseling and eugenics.
- Conditions
- Infantile Hemangioma, Capillary Hemangioma, Capillary Hemangiomas, Hemangioma, Capillary Infantile, Strawberry Hemangioma
- Keywords
- Hemangioma
- Medical subject headings
- Hemangioma, Capillary, Hemangioma, capillary infantile, Hemangioma, Cavernous, Hemangioma
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 |
|---|---|---|
| Infant hemangioma(IH) | Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, We designed the study to collect data about both epidemiology related risk ractors of infantile hemangioma in China. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of infantile hemangioma in China
Data collected by questionnaire of infantile hemangioma, filled by the investigators
Measured: about 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study startDec 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xiaojian, Zhujiang Hospital
- Investigators
- Tangde Zhang, Doctor, Study director, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173352
- Sponsor's protocol ID
- Yao Xiaojian
- Acronym
- IH
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China
- ClinicalTrials.gov ID
- NCT03173352
- Acronym / sponsor ID
- IH / Yao Xiaojian
- Conditions
- Infantile Hemangioma, Capillary Hemangioma, Capillary Hemangiomas, Hemangioma, Capillary Infantile, Strawberry Hemangioma
- Keywords
- Hemangioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Jun 2017 (actual)
- 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.
Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, the investigators designed the study for the following purposes: 1, to aware the incidence of infantile hemangioma and understand the related risk factorsin China; 2, to understand the clinical characteristics of infantile hemangioma and the risk factors for complications; 3, to investigate the level of knowledge, treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of infantile hemangioma in parents and provide more advice for pregnancy counseling and eugenics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant hemangioma(IH) | – | –Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, We designed the study to collect data about both epidemiology related risk ractors of infantile hemangioma in China. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants from the selected community
Key inclusion criteria (2 listed)
- Chinese
- The infants within 12 months of age
Key exclusion criteria (1 listed)
- Those whoes guardian does not want his data to be collected in this study
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
The incidence rate of infantile hemangioma in China
Time frame: about 1 years
Data collected by questionnaire of infantile hemangioma, filled by the investigators
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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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.
Tangde Zhang, Doctor study director
Zhujiang 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 Infantile Hemangioma and Capillary Hemangioma, run by Zhujiang Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian XJ Yao, MBBS (+8613631344241, yaoxiaojian321@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of infantile hemangioma in China (time frame: about 1 years). 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 2 Jun 2017.