Trial record 2 of 18 for:    "glucose-6-phosphate dehydrogenase deficiency"

Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Mahidol University
University of Oxford
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT02069236
First received: February 14, 2014
Last updated: August 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Glucose-6 Phosphate Dehydrogenase Deficiency
Other: G6PD Test

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Correlation of capillary and venous blood results using Trinity quantitative G6PD test [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.


Secondary Outcome Measures:
  • Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard [ Time Frame: six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.


Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: G6PD Testing
All subjects receive G6PD test
Other: G6PD Test
All subjects are tested by multiple G6PD tests
Other Names:
  • Trinity spectrophotometric assay
  • Flow cytometry
  • CareStart
  • Florescent Spot Test

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069236

Locations
Thailand
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Thailand
Sponsors and Collaborators
PATH
Mahidol University
University of Oxford
Investigators
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
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02069236     History of Changes
Other Study ID Numbers: SMRU 1302
Study First Received: February 14, 2014
Last Updated: August 4, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by PATH:
Glucose-6 phosphate dehydrogenase deficiency
capillary
venous
genotype phenotype correlation

Additional relevant MeSH terms:
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014