NCT00577213

Brief Summary

To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

5.7 years

First QC Date

December 18, 2007

Last Update Submit

October 25, 2012

Conditions

Keywords

DiagnosisHemangiomasVascular MalformationsVenular MalformationsVenous MalformationsLymphatic MalformationsArteriovenous Malformations

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with vascular lesions from the patient populations at Arkansas Children's Hospital (ACH) and the University of Arkansas for Medical Sciences (UAMS) will be recruited for the study. Approximately 45 subjects from Arkansas Children's Hospital and approximately 10 subjects from the University of Arkansas for Medical Sciences will be recruited for a total of 55.

You may qualify if:

  • Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations.

You may not qualify if:

  • All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HemangiomaVascular MalformationsLymphatic AbnormalitiesArteriovenous MalformationsDisease

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsCardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gal Shafirstein, Ph.D.

    UAMS, ACH, Central Arkansas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR
  • Jessica L Boswell

    UAMS, ACH, Central Arkansas Veterans Healthcare System

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 26, 2012

Record last verified: 2012-10