HemangiomaNCT00974129
A Study of CCCTC-binding Factor (CTCF) in Infantile Hemangiomas
An observational study of Hemangioma, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor, in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to determine whether or not the CTCF genotype might serve as an early and reliable predictor of tumor growth. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Hemangioma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2012
- 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 Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients to be recruited will include infants with hemangiomas on any part of their body.
Who may be able to join
- Hemangioma must appear within one month prior to enrollment
Who cannot join
- Hemangioma appeared before one month prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Dermatology Associates
New Haven, Connecticut, 06519
About this study
Official title: Infantile Hemangioma Tumor Size and C/T Polymorphism Within CTCF Binding Site Six
The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor, in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to determine whether or not the CTCF genotype might serve as an early and reliable predictor of tumor growth.
Read the detailed description
This study seeks to examine a potential relationship between CTCF genotype and hemangioma size and growth rate. In addition to the initial visit, patients will return to our clinic for evaluation at two weeks, one month, two months, six months, and one year. At each visit, patients' hemangiomas will be measured and photographed. At one point over the course of evaluation, a blood sample will be taken from each patient for evaluation of C/T polymorphism at CTCF binding site six.
- Conditions
- Hemangioma
- Medical subject headings
- Hemangioma
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 |
|---|---|---|
| Patients with Infantile Hemangiomas | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: no subjects were enrolled, study was halted due to study staff departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepak Narayan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974129
- Sponsor's protocol ID
- 0507000430
- Other IDs
- Yale-0430
- Status last verified
- Jun 2014
- First submitted
- 9 Sep 2009
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infantile Hemangioma Tumor Size and C/T Polymorphism Within CTCF Binding Site Six
- ClinicalTrials.gov ID
- NCT00974129
- Acronym / sponsor ID
- 0507000430
- Conditions
- Hemangioma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no subjects were enrolled, study was halted due to study staff departure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Sep 2009 (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 evaluate the genotype of CTCF, a proven transcription factor, in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to determine whether or not the CTCF genotype might serve as an early and reliable predictor of tumor growth.
Detailed description
This study seeks to examine a potential relationship between CTCF genotype and hemangioma size and growth rate. In addition to the initial visit, patients will return to our clinic for evaluation at two weeks, one month, two months, six months, and one year. At each visit, patients' hemangiomas will be measured and photographed. At one point over the course of evaluation, a blood sample will be taken from each patient for evaluation of C/T polymorphism at CTCF binding site six.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Infantile Hemangiomas | – | – |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients to be recruited will include infants with hemangiomas on any part of their body.
Key inclusion criteria (1 listed)
- Hemangioma must appear within one month prior to enrollment
Key exclusion criteria (1 listed)
- Hemangioma appeared before one month prior to enrollment
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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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.
Deepak Narayan, MD principal investigator
Yale University
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, run by Yale University at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 24 Jun 2014. 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 withdrawn before enrolling participants, so there are no results.
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.
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 24 Jun 2014.