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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)

Participant Flow:   Overall Study
    Group 1
STARTED   261 
COMPLETED   261 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 261 
Age 
[Units: Participants]
 
<=18 years   261 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 0.3  (0.1) 
Gender 
[Units: Participants]
 
Female   192 
Male   69 
Region of Enrollment 
[Units: Participants]
 
United States   232 
Spain   13 
Canada   16 


  Outcome Measures

1.  Primary:   Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound   [ Time Frame: 2 years ]

2.  Secondary:   Risk Factors Associated With the Development of Hepatic Hemangiomas   [ Time Frame: 2 years ]

3.  Primary:   Presence of Hepatic Hemangiomas on Abdominal Ultrasound   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: kahorii@cmh.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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