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Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

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ClinicalTrials.gov Identifier: NCT02069236
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : August 19, 2015
Sponsor:
Collaborators:
Mahidol University
University of Oxford
Information provided by (Responsible Party):
PATH

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 24, 2014
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
Correlation of capillary and venous blood results using Trinity quantitative G6PD test [ Time Frame: Six months ]
Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02069236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard [ Time Frame: six months ]
    Percent agreement between the quantitative results of the flow cytometry assay and the quantitative results of the spectrophotometric assay.
  • Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping [ Time Frame: six months ]
    Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests.
  • Concordance between a qualitative G6PD test and the spectrophotometric gold standard [ Time Frame: Six months ]
    Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the quantitative spectrophotometric assay.
  • Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard [ Time Frame: six months ]
    Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
  • Association between flow cytometry-based test and sample genotype [ Time Frame: Six months ]
    Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing G6PD Tests Using Capillary Blood Versus Venous Blood
Official Title  ICMJE Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
Brief Summary In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. As secondary endpoints we will seek to correlate phenotype as determined by quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test evaluation studies.
Detailed Description In this study we propose to determine the correlation in glucose-6 phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. We will also compare results of different G6PD tests with known G6PD genetic profiles. The results of the study will inform design of future G6PD diagnostic development & evaluations. This research will be conducted in MaeSot Thailand, where G6PD deficiency has a high prevalence. Study participants will be recruited into three groups of 50 volunteers per group: 50 G6PD-deficient individuals, 50 G6PD-normal individuals, and 50 G6PD-intermediate individuals. Following a written informed consent, participants will donate about 3 ml of venous blood and about 4 drops of capillary blood (fingerstick). There will be no direct benefit to research participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glucose-6 Phosphate Dehydrogenase Deficiency
Intervention  ICMJE Other: G6PD Test
All subjects are tested by multiple G6PD tests
Other Names:
  • Trinity spectrophotometric assay
  • Flow cytometry
  • CareStart
  • Florescent Spot Test
Study Arms  ICMJE No Intervention: G6PD Testing
All subjects receive G6PD test
Intervention: Other: G6PD Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previous G6PD test at SMRU clinic
  • Patient willing to participate and sign informed consent form
  • Patient willing to allow donated sample to be used in future research
  • Subjects 18 years of age or older

Exclusion Criteria:

  • patients with severe malaria or other severe illness
  • Patients who received a blood transfusion in the last 3 months
  • Patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02069236
Other Study ID Numbers  ICMJE SMRU 1302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PATH
Study Sponsor  ICMJE PATH
Collaborators  ICMJE
  • Mahidol University
  • University of Oxford
Investigators  ICMJE
Principal Investigator: Francois Nosten, MD/PhD Shoklo Malaria Research Unit, Mahidol Oxford Research unit
Study Chair: Gonzalo Domingo, PhD PATH
Study Chair: Germana Bancone, PhD Shoklo Malaria Research Unit, Mahidol Oxford Research unit
Study Chair: Sarah McGray, MPH PATH
PRS Account PATH
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP