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Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT04772911
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this research study is to develop a better understanding of vascular stains and to improve the usual laser treatment for vascular stain by using optical coherence tomography (OCT). This study is being done at the University of Wisconsin-Madison (UW-Madison) and University of California, Irvine. A total of about 85 people will participate in this study.

Condition or disease Intervention/treatment
Vascular Stains Device: Optical Coherence Tomography (OCT)

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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Group/Cohort Intervention/treatment
Vascular Staining
Patients diagnosed with vascular stains.
Device: Optical Coherence Tomography (OCT)
OCT will be performed at baseline and prior to each standard of care laser treatment to characterize the mean diameter and depth of blood vessels.




Primary Outcome Measures :
  1. Correlation between blood vessel size measured via OCT and genotype of affected tissues [ Time Frame: up to 1 month ]
    Targeted next generation sequencing (NGS) using a hybrid capture approach will be performed on DNA samples from affected tissues. OCT measurements of blood vessel size will be compared to genotype derived from biospecimen.


Other Outcome Measures:
  1. Correlation of genotype with phenotype [ Time Frame: up to 1 month ]
    Regression analysis will be used to estimate the effect of genotype on clinical phenotype adjusting for age, sex, race, ethnicity, and other potential confounders.


Biospecimen Retention:   Samples With DNA

Each collection will occur 1 time while the subject is on study if they consent to the sample collection.

  • Blood - approximately 4mL will be collected (approximately 5 min)
  • Saliva Sample - 1-2 tubes of saliva will be collected (approximately 2 min)
  • Skin Punch Biopsy (affected and normal skin area) - one or two 3-4mm punch biopsy will be taken (approximately 20 min)
  • Fresh surgical tissue - a small amount of fresh tissue, at least 3-4mm in diameter (no time commitment from the subject)
  • Slides/blocks - up to 10 unstained slides or a block of archived tissue will be requested. (no time commitment from the participant)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with a vascular stain on any anatomic location based on the discretion of the study physician
Criteria

Inclusion Criteria:

  • Individual of any age from infant to adult
  • Diagnosed with a vascular stain on any anatomic location based on the discretion of the study physician
  • Has elected to receive standard of care laser treatment for their vascular stain

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772911


Contacts
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Contact: Heather Neils (608) 287-2640 hneils@dermatology.wisc.edu

Locations
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United States, California
University of California Not yet recruiting
Irvine, California, United States, 92697
Sub-Investigator: Kristen Kelly, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53715
Contact: Heather Neils    608-287-2640    hneils@dermatology.wisc.edu   
Principal Investigator: Lisa Arkin, MD         
Sub-Investigator: Beth Drolet, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Lisa Arkin, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04772911    
Other Study ID Numbers: 2020-1351
A534300 ( Other Identifier: UW Madison )
SMPH/DERMATOLOGY ( Other Identifier: UW Madison )
Protocol Version 2/19/2021 ( Other Identifier: UW Madison )
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No