A Prospective Study on the Incidence and Related Risk Fac... | NCT03173352

Studies
A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

NCT03173352

Sponsor

Zhujiang Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2017Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Infantile Hemangioma
Capillary Hemangioma
Capillary Hemangiomas
Hemangioma, Capillary Infantile
Strawberry Hemangioma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

May 29, 2017

First Submission Date that Met QC Criteria

May 31, 2017

First Posted Date

Jun 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence rate of infantile hemangioma in China	Data collected by questionnaire of infantile hemangioma, filled by the investigators	about 1 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese
The infants within 12 months of age

Exclusion Criteria:

Those whoes guardian does not want his data to be collected in this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

All infants from the selected community

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaojian XJ Yao, MBBS	Contact	+8613631344241		yaoxiaojian321@163.com

Overall Officials

Name	Affiliation	Role
Tangde Zhang, Doctor	Zhujiang Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhujiang Hospital	Recruiting	Guangzhou	Guangdong	510515	China

Condition Browse Module

MeSH Terms

ID	Term
D018324	Hemangioma, Capillary
C535860	Hemangioma, capillary infantile
D006392	Hemangioma, Cavernous
D006391	Hemangioma

Ancestor Terms

ID	Term
D009383	Neoplasms, Vascular Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D000096826	Cavernous Sinus Syndromes

Browse Leaves

Not provided

Browse Branches

Not provided