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Microassay and Allergy Skin Prick Test Correlation Study

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ClinicalTrials.gov Identifier: NCT03514303
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
United Allergy Services

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.

Condition or disease Intervention/treatment
Allergy Pollen Diagnostic Test: Spiriplex Allergenex Microassay

Detailed Description:

Prospective subjects for study entry will initially be screened by the results of their allergy skin test that were acquired within the past two years. In order to be a prospective subject positive SPT results of five of the following ten allergens will be required: Dust Mite, Ragweed, Cat Dander, Johnson Grass, Bermuda Grass, Timothy Grass, Oak, Cladosporium, Dog Dander, and Cockroach. After signing an IRB approved consent form, these patients will undergo a finger prick blood draw and blot. This study will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.

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 SCIT immunotherapy will be enrolled.

Sub-investigator(s) will screen patient charts from a database of patients previously tested using the UAS protocol. Patients that qualify based on inclusion criteria will be contacted by phone and asked if they would be willing to participate in this study.

Subject arrives to the clinic and all inclusion and exclusion criteria are verified by their primary physician and the sub-investigator. Sub-investigator insures that the IRB verified consent form is signed and that the patient has no questions. 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. The microassay results will be sent to the primary investigation site for correlation analysis with the previously logged SPT results. These results will be blinded to the statisticians and researchers that will be determining potential correlation between SPT and microassay results.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Microassay and Allergy Skin Prick Test Correlation Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Ragweed
Subjects will test positive or negative to the allergen Ragweed.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Timothy Grass
Subjects will test positive or negative to the allergen Timothy Grass.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Johnson Grass
Subjects will test positive or negative to the allergen Johnson Grass.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Bermuda Grass
Subjects will test positive or negative to the allergen Bermuda Grass.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Cladosporium
Subjects will test positive or negative to the allergen Cladosporium.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Cat Dander
Subjects will test positive or negative to the allergen Cat Dander.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Cockroach
Subjects will test positive or negative to the allergen Cockroach.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Dust Mite
Subjects will test positive or negative to the allergen Dust Mite.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Oak
Subjects will test positive or negative to the allergen Oak.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Dog Dander
Subjects will test positive or negative to the allergen Dog Dander.
Diagnostic Test: Spiriplex Allergenex Microassay
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.




Primary Outcome Measures :
  1. Microassay Tests Completion [ Time Frame: 2-3 months ]
    All patients will be tested by microassay for the 10 allergen groups for comparison to historic skin prick tests of the same 10 allergens.


Biospecimen Retention:   Samples With DNA
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.


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion 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.

Exclusion Criteria:

  • Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.

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): NCT03514303


Contacts
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Contact: William W Wagoner, BS 210-679-3926 william.wagoner@unitedallergy.com

Locations
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United States, Texas
United Allergy Services Recruiting
San Antonio, Texas, United States, 78216
Contact: William W Wagoner, BS    210-679-3926    william.wagoner@unitedallergy.com   
Sponsors and Collaborators
United Allergy Services

Additional Information:

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Responsible Party: United Allergy Services
ClinicalTrials.gov Identifier: NCT03514303     History of Changes
Other Study ID Numbers: Microassay study-1
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by United Allergy Services:
Skin test, Microarray test
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases