Hemangioma, CapillaryNCT05080868
Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution
An observational study of Hemangioma, Capillary, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemangioma, Capillary
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2021to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Those whoes guardian does not want his data to be collected in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemangioma, Capillary
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abortive hemangioma among infantile hemangioma
Proportion of abortive hemangioma among infantile hemangioma
Measured: baseline
Secondary outcomes (13)
To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex
Compare sex predominance between infantile hemangioma and abortive hemangioma
Measured: baseline
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity
Compare prematurity rates between infantile hemangiomas and abortive hemangiomas
Measured: baseline
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight
Compare birthweight between infantile hemangiomas and abortive hemangiomas
Measured: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization
Compare localization between infantile hemangiomas and abortive hemangiomas
Measured: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment
le hemangiomas and abortive hemangiomaCompare treatment between infanti
Measured: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : complications
Compare complications between infantile hemangiomas and abortive hemangioma
Measured: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : size
Compare size (focal, extended or segmental) between infantile hemangiomas and abortive hemangioma
Measured: baseline
To study the evolution of abortive hemangioma : erythematous macule
Evaluation of the fading of erythematous macule between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
To study the evolution of abortive hemangioma : papules of proliferation
Evaluation of the regression of the papules of proliferation between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
To study the evolution of abortive hemangioma : telangiectasias
Evaluation of the fading of telangiectasias between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
To study the evolution of abortive hemangioma : halo of vasoconstriction
Evaluation of the fading of the vasoconstricted halo between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
To study the evolution of abortive hemangioma : areas of vasoconstriction
Evaluation of the fading of vasoconstricted areas between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
To study the evolution of abortive hemangioma : dilated veins
Evaluation of the fading of dilated veins between the stage of maximal proliferation and the last follow-up
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start23 Mar 2021
- Primary completion30 May 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemangioma, CapillaryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BURSZTEJN Anne-Claire, MD, PhD, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080868
- Sponsor's protocol ID
- 2019PI221
- Status last verified
- Oct 2021
- First submitted
- 12 Mar 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Epidemiological and Clinical Characteristics of Infantile Hemangioma With Minimal or Arrested Growth (IH-MAG) and Classic Infantile Hemangioma : a Retrospective Study
- ClinicalTrials.gov ID
- NCT05080868
- Acronym / sponsor ID
- 2019PI221
- Conditions
- Hemangioma, Capillary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Those whoes guardian does not want his data to be collected in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of abortive hemangioma among infantile hemangioma
Time frame: baseline
Proportion of abortive hemangioma among infantile hemangioma
13 secondary outcomes
To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex
Time frame: baseline
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity
Time frame: baseline
To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight
Time frame: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization
Time frame: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment
Time frame: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : complications
Time frame: baseline
To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : size
Time frame: baseline
To study the evolution of abortive hemangioma : erythematous macule
Time frame: 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
To study the evolution of abortive hemangioma : telangiectasias
Time frame: 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
To study the evolution of abortive hemangioma : areas of vasoconstriction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BURSZTEJN Anne-Claire, MD, PhD study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, Capillary, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of abortive hemangioma among infantile hemangioma (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.