Glucose-6 Phosphate Dehydrogenase Deficiency Clinical Trial
Official title:
Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
| Verified date | February 2014 |
| Source | PATH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | December 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Shoklo Malaria Research Unit (SMRU) | Mae Sot |
| Lead Sponsor | Collaborator |
|---|---|
| PATH | Mahidol University, University of Oxford |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation of capillary and venous blood results using Trinity quantitative G6PD test | Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood. | Six months | No |
| Secondary | Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard | Percent agreement between the quantitative results of the flow cytometry assay and the quantitative results of the spectrophotometric assay. | six months | No |
| Secondary | Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping | Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests. | six months | No |
| Secondary | Concordance between a qualitative G6PD test and the spectrophotometric gold standard | Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the quantitative spectrophotometric assay. | Six months | No |
| Secondary | Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard | Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard | six months | No |
| Secondary | Association between flow cytometry-based test and sample genotype | Determine accuracy of phenotypic results of flow cytometry assay against genetic profile. | Six months | No |