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
|Condition or disease||Intervention/treatment|
|Vascular Stains||Device: Optical Coherence Tomography (OCT)|
|Study Type :||Observational|
|Estimated Enrollment :||85 participants|
|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|
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.
- 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.
- 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)
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
|Contact: Heather Neils||(608) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Lisa Arkin, MD|
|Sub-Investigator: Beth Drolet, MD|
|Principal Investigator:||Lisa Arkin, MD||University of Wisconsin, Madison|