Glucose-6 Phosphate Dehydrogenase DeficiencyNCT02069236
Comparing G6PD Tests Using Capillary Blood Versus Venous Blood
A study testing G6PD Test in people with Glucose-6 Phosphate Dehydrogenase Deficiency, run by PATH at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose-6 Phosphate Dehydrogenase Deficiency
- What is being tested?
- G6PD Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
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.
Read the 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.
- Being tested
- G6PD Test
- Keywords
- Glucose-6 phosphate dehydrogenase deficiency, capillary, venous, genotype phenotype correlation
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G6PD TestOther
Also called Trinity spectrophotometric assay, Flow cytometry, CareStart, Florescent Spot Test
All subjects are tested by multiple G6PD tests
| Study group | Role | What they receive |
|---|---|---|
| G6PD Testing | No intervention | All subjects receive G6PD test Receives: Other: G6PD Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (5)
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.
Measured: six months
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.
Measured: six months
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.
Measured: Six months
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
Measured: six months
Association between flow cytometry-based test and sample genotype
Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose-6 Phosphate Dehydrogenase DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, MD/PhD, Principal investigator, Shoklo Malaria Research Unit, Mahidol Oxford Research unitGonzalo Domingo, PhD, Study chair, PATHGermana Bancone, PhD, Study chair, Shoklo Malaria Research Unit, Mahidol Oxford Research unitSarah McGray, MPH, Study chair, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069236
- Sponsor's protocol ID
- SMRU 1302
- Status last verified
- Feb 2014
- First submitted
- 14 Feb 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
- ClinicalTrials.gov ID
- NCT02069236
- Acronym / sponsor ID
- SMRU 1302
- Keywords
- Glucose-6 phosphate dehydrogenase deficiency, capillary, venous, genotype phenotype correlation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Mahidol University, University of Oxford
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G6PD Testing | No intervention | Other: G6PD TestAll subjects receive G6PD test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G6PD TestAlso: Trinity spectrophotometric assay, Flow cytometry, CareStart, Florescent Spot TestAll subjects are tested by multiple G6PD tests | Other | G6PD Testing |
Primary outcome
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.
5 secondary outcomes
Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard
Time frame: six months
Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping
Time frame: six months
Concordance between a qualitative G6PD test and the spectrophotometric gold standard
Time frame: Six months
Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard
Time frame: six months
Association between flow cytometry-based test and sample genotype
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Nosten, MD/PhD principal investigator
Shoklo Malaria Research Unit, Mahidol Oxford Research unit
Gonzalo Domingo, PhD study chair
PATH
Germana Bancone, PhD study chair
Shoklo Malaria Research Unit, Mahidol Oxford Research unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G6PD Test in people with Glucose-6 Phosphate Dehydrogenase Deficiency, run by PATH at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of capillary and venous blood results using Trinity quantitative G6PD test (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.