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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
    • Grand-Est
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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