Microassay and Allergy Skin Prick Test Correlation Study
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this study is to evaluate the potential correlation of the results of allergen-specific skin prick tests (SPT) to that of allergen-specific microarray determination (microassay test). Subjects who meet enrollment criteria, after signing an IRB approved consent form, will perform a minor finger prick blood draw and blot to be mailed off for microassay analysis. Specific statistical analysis will be done to assess all potential correlations between SPT and microassay. This study design should enable assessment of the level of correlation between SPT results and microassay results for specified allergens within a cohort of subjects with allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedFirst Posted
Study publicly available on registry
May 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedOctober 17, 2018
January 1, 2018
10 months
January 25, 2018
October 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microassay Tests Completion
All patients will be tested by microassay for the 10 allergen groups for comparison to historic skin prick tests of the same 10 allergens.
2-3 months
Study Arms (10)
Ragweed
Subjects will test positive or negative to the allergen Ragweed.
Timothy Grass
Subjects will test positive or negative to the allergen Timothy Grass.
Johnson Grass
Subjects will test positive or negative to the allergen Johnson Grass.
Bermuda Grass
Subjects will test positive or negative to the allergen Bermuda Grass.
Cladosporium
Subjects will test positive or negative to the allergen Cladosporium.
Cat Dander
Subjects will test positive or negative to the allergen Cat Dander.
Cockroach
Subjects will test positive or negative to the allergen Cockroach.
Dust Mite
Subjects will test positive or negative to the allergen Dust Mite.
Oak
Subjects will test positive or negative to the allergen Oak.
Dog Dander
Subjects will test positive or negative to the allergen Dog Dander.
Interventions
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Eligibility Criteria
Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled. They will have performed an allergen specific skin prick test within the last 2 years through United Allergy Services.
You may qualify if:
- Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled.
You may not qualify if:
- Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
United Allergy Services
San Antonio, Texas, 78216, United States
Biospecimen
Subject or sub-investigator will perform the finger prick and blot using the instructions listed on the Allergenex sample collection packet. The sample will be mailed to Spiriplex to be analyzed using their microarray device.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2018
First Posted
May 2, 2018
Study Start
April 1, 2018
Primary Completion
February 1, 2019
Study Completion
June 1, 2019
Last Updated
October 17, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share