- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080868
Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution
October 4, 2021 updated by: Central Hospital, Nancy, France
Comparing Epidemiological and Clinical Characteristics of Infantile Hemangioma With Minimal or Arrested Growth (IH-MAG) and Classic Infantile Hemangioma : a Retrospective Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
224
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Grand-Est
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Nancy, Grand-Est, France, 54000
- CHRU de Nancy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Those whoes guardian does not want his data to be collected in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of abortive hemangioma among infantile hemangioma
Time Frame: baseline
|
Proportion of abortive hemangioma among infantile hemangioma
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex
Time Frame: baseline
|
Compare sex predominance between infantile hemangioma and abortive hemangioma
|
baseline
|
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity
Time Frame: baseline
|
Compare prematurity rates between infantile hemangiomas and abortive hemangiomas
|
baseline
|
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight
Time Frame: baseline
|
Compare birthweight between infantile hemangiomas and abortive hemangiomas
|
baseline
|
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization
Time Frame: baseline
|
Compare localization between infantile hemangiomas and abortive hemangiomas
|
baseline
|
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment
Time Frame: baseline
|
le hemangiomas and abortive hemangiomaCompare treatment between infanti
|
baseline
|
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : complications
Time Frame: baseline
|
Compare complications between infantile hemangiomas and abortive hemangioma
|
baseline
|
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : size
Time Frame: baseline
|
Compare size (focal, extended or segmental) between infantile hemangiomas and abortive hemangioma
|
baseline
|
To study the evolution of abortive hemangioma : erythematous macule
Time Frame: through study completion, an average of 4 years
|
Evaluation of the fading of erythematous macule between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
To study the evolution of abortive hemangioma : papules of proliferation
Time Frame: through study completion, an average of 4 years
|
Evaluation of the regression of the papules of proliferation between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
To study the evolution of abortive hemangioma : telangiectasias
Time Frame: through study completion, an average of 4 years
|
Evaluation of the fading of telangiectasias between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
To study the evolution of abortive hemangioma : halo of vasoconstriction
Time Frame: through study completion, an average of 4 years
|
Evaluation of the fading of the vasoconstricted halo between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
To study the evolution of abortive hemangioma : areas of vasoconstriction
Time Frame: through study completion, an average of 4 years
|
Evaluation of the fading of vasoconstricted areas between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
To study the evolution of abortive hemangioma : dilated veins
Time Frame: through study completion, an average of 4 years
|
Evaluation of the fading of dilated veins between the stage of maximal proliferation and the last follow-up
|
through study completion, an average of 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: BURSZTEJN Anne-Claire, MD, PhD, Central Hospital, Nancy, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 23, 2021
Primary Completion (ACTUAL)
May 30, 2021
Study Completion (ACTUAL)
August 15, 2021
Study Registration Dates
First Submitted
March 12, 2021
First Submitted That Met QC Criteria
October 4, 2021
First Posted (ACTUAL)
October 18, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 4, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019PI221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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