NCT03331744

Brief Summary

The primary purpose of this study is to identify the clinical characteristics of infantile hemangioma (IH) in our single center in China. The second objective of the study is to identify the clinical features of infantile hepatic hemangioma (IHH) and ulceration in patients with IHs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

8.2 years

First QC Date

October 12, 2017

Last Update Submit

January 23, 2024

Conditions

Hemangioma

Keywords

Infantile hemangiomaInfantile hepatic hemangiomaUlcerated infantile hemangiomaClinical characteristicsDemographic characteristics

Outcome Measures

Primary Outcomes (1)

  • Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients.

    Clinical characteristics of infantile hemangioma. Phase of growth include proliferation, plateau and involution phase. Morphologic subtypes include localized, segmental, indeterminate and multifocal type.

    2 years

Secondary Outcomes (4)

  • Demographic information of IH about patient gender, birth weight, race, gestational age, prenatal testing procedures, placental abnormalities, maternal complications during pregnancy, type of fertilization and delivery type are collected.

    2 years

  • Demographic information of IHH about patient gender, birth weight, race, gestational age, prenatal testing procedures, placental abnormalities, maternal complications during pregnancy, type of fertilization and delivery type are collected.

    2 years

  • Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.

    2 years

  • Location, size, complication and outcome in patients with ulcerated IHs.

    2 years

Eligibility Criteria

AgeUp to 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients with the diagnosis of IHs will be recruited from the Department of Pediatric Surgery, West China Hospital of Sichuan University.

You may qualify if:

  • Age ≤6 years old
  • Diagnose of IHs
  • Consent of both parents (or the person having parental authority in families)

You may not qualify if:

  • Congenital hemangioma, kaposiform hemangioendothelioma, or other vascular anomalies
  • Age\>6 years
  • Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments
  • Patients with an inability to participate or to follow the study treatment and assessment plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (4)

  • Zhang K, Qiu T, Zhou J, Gong X, Lan Y, Zhang Z, Ji Y. Comparison of Infantile Hemangiomas in Male and Female Infants: A Prospective Study. J Dermatol. 2025 Oct;52(10):1555-1560. doi: 10.1111/1346-8138.17885. Epub 2025 Jul 25.

    PMID: 40715016DERIVED

  • Zhou J, Zhang Z, Lan Y, Yang M, Qiu T, Yang K, Zhang X, Jiang X, Hou F, Shan W, Kong F, Hu F, Chen S, Ji Y. Long-Term Outcomes of Oral Propranolol for Facial Infantile Hemangioma. Plast Reconstr Surg. 2026 Jan 1;157(1):142-149. doi: 10.1097/PRS.0000000000012186. Epub 2025 May 6.

    PMID: 40327835DERIVED

  • Gong X, Yang M, Zhang Z, Qiu T, Zhou J, Shan W, Zhang X, Lan Y, Bao P, Zhou Z, Yang C, Zhang Y, Li T, Guo J, Guo J, Lu G, Kong F, Zhang Y, Chen S, Ji Y. Clinical characteristics and managements of congenital hepatic hemangioma: a cohort study of 211 cases. Hepatol Int. 2025 Jun;19(3):682-691. doi: 10.1007/s12072-024-10756-5. Epub 2024 Nov 29.

    PMID: 39612031DERIVED

  • Gong X, Qiu T, Feng L, Yang K, Dai S, Zhou J, Zhang X, Chen S, Ji Y. Maternal and Perinatal Risk Factors for Infantile Hemangioma: A Matched Case-Control Study with a Large Sample Size. Dermatol Ther (Heidelb). 2022 Jul;12(7):1659-1670. doi: 10.1007/s13555-022-00756-4. Epub 2022 Jun 25.

    PMID: 35751738DERIVED

MeSH Terms

Conditions

HemangiomaHemangioma, Capillary

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yi Ji

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ji

CONTACT

+86 02885423453jijiyuanyuan@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2017

First Posted

November 6, 2017

Study Start

October 6, 2017

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)