Clinical trial NCT02069236: Comparing G6PD Tests Using Capillary Blood Versus Venous Blood
Official title: Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose-6 Phosphate Dehydrogenase Deficiency
Keywords: Glucose-6 phosphate dehydrogenase deficiency
capillary
venous
genotype phenotype correlation
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: University of Oxford
First posted: 2014-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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)

Primary outcomes:
measure: Correlation of capillary and venous blood results using Trinity quantitative G6PD test
timeFrame: Six months
Secondary outcomes:
measure: Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard
timeFrame: six months
measure: Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping
timeFrame: six months
measure: Concordance between a qualitative G6PD test and the spectrophotometric gold standard
timeFrame: Six months
measure: Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard
timeFrame: six months
measure: Association between flow cytometry-based test and sample genotype
timeFrame: Six months
Other outcomes:
Locations:
city: Mae Sot
country: Thailand
facility: Shoklo Malaria Research Unit (SMRU)
Study officials:
affiliation: Shoklo Malaria Research Unit, Mahidol Oxford Research unit
name: Francois Nosten, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PATH
name: Gonzalo Domingo, PhD
role: STUDY_CHAIR
affiliation: Shoklo Malaria Research Unit, Mahidol Oxford Research unit
name: Germana Bancone, PhD
role: STUDY_CHAIR
affiliation: PATH
name: Sarah McGray, MPH
role: STUDY_CHAIR
References: