Clinical Characteristics of Infantile Hemangioma

Hemangioma Clinical Trial

Official title:

Clinical Characteristics of Infantile Hemangioma: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331744
• Other study ID #: 2017-118
• Status: Recruiting
• Start date: October 6, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: West China Hospital
• Contact: Yi Ji
• Phone: +86 02885423453
• Email: jijiyuanyuan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Infantile hemangioma (IH) is the most common benign tumor of infancy with an estimated prevalence of 4%-5%. IHs may be presented in any part of body including the visceral organs, but are preferentially located on the face, head and neck area. IHs exhibit a characteristic life cycle consisting of a rapid proliferating phase within the first year of life followed by a slowly involuted phase lasting for up to five years. Although most resolve over time without major sequelae, a significant subset can result in severe complications including disfiguring and ulceration, some even could impair organ functions and threaten patients' life. Risk factors of IHs have been identified including multiple gestation, low birth weight, prematurity, white race, eclampsia and placental abnormalities. However, the exact occurrence, clinical features and risk factors of IHs is still unknown in Chinese patients because of the lack of large scale of prospective studies. In addition, characteristics of ulceration of IHs and infantile hepatic hemangiomas (IHHs) are also not well documented. Therefore, it's important to perform this prospective study to determine the clinical features of Chinese patients with IHs, and this study will also make contributions to the prevents, diagnoses and treatments of IHs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Age =6 years old

• Diagnose of IHs

• Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Demographic characteristics in patients with IH.	2 years
Secondary	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.	Demographic characteristics in patients with infantile hepatic hemangioma.	2 years
Secondary	Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.	Clinical characteristics of infantile hepatic hemangioma	2 years
Secondary	Location, size, complication and outcome in patients with ulcerated IHs.	Clinical characteristics of ulcerated IHs. Phase of growth include proliferation, plateau and involution, and morphologic subtypes include localized, segmental, indeterminate and multifocal type.	2 years