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临床试验/NCT03331744
NCT03331744招募中不适用

Clinical Characteristics of Infantile Hemangioma: a Prospective Study

West China Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 2 years

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Ji

Principal Investigator

West China Hospital

研究点 (1)

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