Clinical Characteristics of Infantile Hemangioma

NCT ID: NCT03331744

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-06

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemangioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Ji

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Ji

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Ji

Role: CONTACT

+86 02885423453

Facility Contacts

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Yi Ji, MD, PhD

Role: primary

+86 28 85423453

Siyuan Chen

Role: backup

+86 28 85423460

References

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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 Jul 25. doi: 10.1111/1346-8138.17885. Online ahead of print.

Reference Type DERIVED
PMID: 40715016 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39612031 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35751738 (View on PubMed)

Other Identifiers

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2017-118

Identifier Type: -

Identifier Source: org_study_id

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