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Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010695
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
PATH

Brief Summary:
Cross-sectional diagnostic accuracy study with up to 250 patient participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 ethylenediaminetetraacetic acid (EDTA) whole blood tubes and obtain finger stick capillary blood. Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate Dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the EDTA anti-coagulated venous blood samples. Another EDTA anti-coagulated venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified lab for G6PD reference testing by the gold standard assay: G6PD measurement by spectrophotometry; this sample will also have a hemoglobin measurement by a hematology analyzer. Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

Condition or disease Intervention/treatment Phase
G6PD Deficiency Diagnostic Test: STANDARD G6PD Not Applicable

Detailed Description:

Objective To assess the accuracy of a POC G6PD test as compared to a reference assay in detecting G6PD activity

Endpoints

  • Sensitivity and specificity of SD Biosensor POC G6PD test compared to the Pointe Scientific test kit for identifying G6PD deficient individuals and women with intermediate G6PD activity
  • Accuracy between the SD Biosensor POC G6PD test measure of G6PD activity and the Pointe Scientific test kit
  • Accuracy between the SD Biosensor POC G6PD test measure of hemoglobin (Hb) and HemoCue 201+, a point of care reference haemoglobin assay
  • Comparison of the SD Biosensor POC G6PD test results for capillary and venous samples.

Population 250 male and female participants 18-65 years of age presenting at the clinic for care. Individuals who have received a blood transfusion within the last 3 months, according to self-report, will be excluded.

Study sites Prevention Center, Fred Hutch Cancer Research Center University of Washington

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : December 1, 2019


Arm Intervention/treatment
screening with STANDARD G6PD Test
all participants recruited in the study will be screened with an investigational IVD- STANDARD G6PD Test. The investigational test will not be used to determine any treatment or case-management
Diagnostic Test: STANDARD G6PD
The STANDARD G6PD Analyzer is designed to measure the quantitative determination of total Hb concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product. System components shall be labeled in accordance with regulatory requirements, including the following statement, "For Investigational Use Only. The performance characteristics of this product have not been established."
Other Name: SD Biosensor G6PD Test




Primary Outcome Measures :
  1. Sensitivity and specificity of the POC G6PD test [ Time Frame: 6 months ]
    Sensitivity and specificity of SD Biosensor POC G6PD test compared to the Pointe Scientific test kit for identifying G6PD deficient individuals and women with intermediate G6PD activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Willingness to provide consent

Exclusion Criteria:

-Blood transfusion in the past 90 days by self-report


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): NCT04010695


Locations
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United States, Washington
Fred Hutchison Prevention Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
PATH
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: James Kublin, MD, MPH Fred Hutchinson Cancer Research Center
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT04010695    
Other Study ID Numbers: G6PD Validation Seattle
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planning to share IPD to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by PATH:
G6PD deficiency
Additional relevant MeSH terms:
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Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases