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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

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ClinicalTrials.gov Identifier: NCT00374335
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : September 12, 2011
Last Update Posted : September 16, 2011
Sponsor:
Collaborators:
Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Northwestern University
St. Justine's Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Hemangioma
Interventions Procedure: abdominal ultrasound
Other: Dermatologic Examination
Enrollment 261

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Period Title: Overall Study
Started 261
Completed 261
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Overall Number of Baseline Participants 261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants
<=18 years
261
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants
0.3  (0.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants
Female
192
  73.6%
Male
69
  26.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 261 participants
United States 232
Spain 13
Canada 16
1.Primary Outcome
Title Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Overall Number of Participants Analyzed 261
Measure Type: Number
Unit of Measure: participants
24
2.Primary Outcome
Title Presence of Hepatic Hemangiomas on Abdominal Ultrasound
Time Frame 2 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Risk Factors Associated With the Development of Hepatic Hemangiomas
Hide Description Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Overall Number of Participants Analyzed 261
Measure Type: Number
Unit of Measure: participants
24
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/261 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/261 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Kimberly Horii
Organization: Children's Mercy Hospitals and Clinics
Phone: 816-234-3924
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00374335     History of Changes
Other Study ID Numbers: 06 02 029E
First Submitted: September 7, 2006
First Posted: September 11, 2006
Results First Submitted: August 9, 2011
Results First Posted: September 12, 2011
Last Update Posted: September 16, 2011