Hemangioma, Vascular AnomaliesNCT00466375
Genetic Basis of Hemangiomas
An observational study of Hemangioma, Vascular Anomalies, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemangioma, Vascular Anomalies
- What is being tested?
- Cheek cell samples or blood sample (4mL) and Cheek cell sample or blood sample (4mL)
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinics from Children's Hospital of Wisconsin.
Study Population Inclusion Criteria:
- No limit to age
- Diagnosis of infantile hemangioma and/or vascular anomaly
- Unaffected twin sibling
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
Study Population Exclusion Criteria:
- Diagnosis other than infantile hemangioma or vascular anomaly
- If the lesion has resolved and cannot be confirmed as a hemangioma by clinical exam
- If the biologic parents are unwilling or unable to submit DNA samples the child will be excluded from the DNA study. Therefore, if DNA samples cannot be or are not obtained from both biologic parents, the child and family will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with infantile hemangioma. There are very few medications to treat infants with hemangiomas.
Read the detailed description
WHAT IS INVOLVED IN THE RESEARCH STUDY?
- Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from child being seen in the Dermatology clinic having infantile hemangioma or vascular anomaly
- Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from parents of child
If you and your child agree to be in this study, the following will happen:
- Informed consent and permission to use or disclose your/your child's health information for research purposes will be obtained by Dr. Drolet, the principal investigator, or her research team. You will receive a copy of this consent form.
- A buccal swab or blood sample will be obtained from you and your child; buccal sampling involves rubbing the inside of your cheek and removing cells to perform a genetic test called "Genomewide Association (GWA).
We expect you and your child to be involved in this study until you and your child have the genetic testing performed.
- Conditions
- Hemangioma, Vascular Anomalies
- Being tested
- Cheek cell samples or blood sample (4mL), Cheek cell sample or blood sample (4mL)
- Keywords
- hemangioma, vascular anomaly, infantile hemangioma
- Medical subject headings
- Hemangioma, Vascular Malformations, Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheek cell samples or blood sample (4mL)Genetic
DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.
Cheek cell sample or blood sample (4mL)Genetic
DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with a hemangioma. Receives: Genetic: Cheek cell samples or blood sample (4mL) | |
| B. | Patients with a vascular anomaly. Receives: Genetic: Cheek cell sample or blood sample (4mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNP
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemangioma, Vascular AnomaliesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Family based
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Beth A Drolet, MD, Medical College of Wisconsin
- Investigators
- Beth Drolet, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466375
- Sponsor's protocol ID
- Genetics of Hemangioma
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2007
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Hemangiomas
- ClinicalTrials.gov ID
- NCT00466375
- Acronym / sponsor ID
- Genetics of Hemangioma
- Conditions
- Hemangioma, Vascular Anomalies
- Keywords
- hemangioma, vascular anomaly, infantile hemangioma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Apr 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Apr 2007 (estimated)
- 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.
The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with infantile hemangioma. There are very few medications to treat infants with hemangiomas.
Detailed description
WHAT IS INVOLVED IN THE RESEARCH STUDY?
- Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from child being seen in the Dermatology clinic having infantile hemangioma or vascular anomaly
- Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from parents of child
If you and your child agree to be in this study, the following will happen:
- Informed consent and permission to use or disclose your/your child's health information for research purposes will be obtained by Dr. Drolet, the principal investigator, or her research team. You will receive a copy of this consent form.
- A buccal swab or blood sample will be obtained from you and your child; buccal sampling involves rubbing the inside of your cheek and removing cells to perform a genetic test called "Genomewide Association (GWA).
We expect you and your child to be involved in this study until you and your child have the genetic testing performed.
Study design
- Observational model
- Family based
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Genetic: Cheek cell samples or blood sample (4mL)Patients with a hemangioma. |
| B. | – | Genetic: Cheek cell sample or blood sample (4mL)Patients with a vascular anomaly. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinics from Children's Hospital of Wisconsin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheek cell samples or blood sample (4mL)DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma. | Genetic | A |
| Cheek cell sample or blood sample (4mL)DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly. | Genetic | B. |
Primary outcome
SNP
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Beth Drolet, MD principal investigator
Medical College of Wisconsin
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, Vascular Anomalies, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2017. 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 United States. 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 was stopped early. Results are not available in the source record.
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?
SNP (time frame: 3 years). 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 29 Aug 2017.