NCT05080868

Brief Summary

Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

March 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

March 12, 2021

Last Update Submit

October 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of abortive hemangioma among infantile hemangioma

    Proportion of abortive hemangioma among infantile hemangioma

    baseline

Secondary Outcomes (13)

  • To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex

    baseline

  • To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity

    baseline

  • To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight

    baseline

  • To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization

    baseline

  • To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment

    baseline

  • +8 more secondary outcomes

Study Arms (2)

Infantile hemangioma with minimal or arrested growth

Epidemiological and clinical characteristics of infantile hemangioma with minimal or arrested growth.

Classic infantile hemangioma

Epidemiological and clinical characteristics of classic infantile hemangioma.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

\- Children between 0 and 18 years old followed in the dermatology department of CHRU de Nancy between January 2014 and December 2020 presenting with one or more infantile hemangioma

You may qualify if:

  • Children between 0 and 18 years old
  • Followed in the dermatology department of CHRU de Nancy between January 2014 and December 2020
  • Presenting with one or more infantile hemangioma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, Grand Est, 54000, France

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • BURSZTEJN Anne-Claire, MD, PhD

    Central Hospital, Nancy, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2021

First Posted

October 18, 2021

Study Start

March 23, 2021

Primary Completion

May 30, 2021

Study Completion

August 15, 2021

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations