ValidationBiosensorsNCT02625285
Validation of New G6PD Point of Care Tests Against Gold Standard Quantitative
An observational study of Validation and Biosensors, run by University of Oxford at 1 site in Thailand.
Trial summary
This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validation, Biosensors, Genotyping
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 24 Jan 2017to 31 Jan 2018
- Phase
- Observational
- 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
Study population: The total sample size will be 150 patients, using targeted enrollment to achieve a convenience sample of approximately 50 G6PD deficient volunteers (male and female), approximately 50 G6PD intermediate or heterozygous female volunteers, and the remaining will be G6PD-normal volunteers with a 1:1 male/female ratio.
Who may be able to join
- Subjects with age ≥ 18 years
- Subjects willing to participate and sign informed consent form
- Male and Female
- Previously tested G6PD deficient, G6PD normal and G6PD intermediate or heterozygous for G6PD variants at SMRU clinic
Who cannot join
- Patients with severe malaria or other severe or any acute 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)
- Patients who have not had a critical illness or received other hemolytic drugs (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: Validation of New G6PD Point of Care Tests (Biosensors) Against Gold Standard Quantitative Spectrophotometry and Genotyping
This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping.
Read the detailed description
Radical cure of P. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative G6PD tests. Different regimens of drug might be more appropriate in subjects with intermediate G6PD activity which can be currently measured only in well equipped laboratories. Validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against Plasmodium vivax.
This study will evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 G6PD-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 G6PD-heterozygous women with intermediate activity, and approximately 50 G6PD-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. The home visitor will explain study details and invite to participate in the study. If the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care.
After signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. The blood from capillary sample will be used to assess G6PD activity using the POC tests, CBC and laboratory based quantitative tests. The venous blood will be used for reference standard quantitative G6PD assays, Hb typing analysis, CBC and buffy-coat will be stored for DNA extraction for G6PD genotyping only; leftover blood will be discarded.
- Conditions
- Validation, Biosensors, Genotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| G6PD Deficient Volunteers | * Subjects with age ≥ 18 years * Male and female * Previously tested G6PD deficient at SMRU clinic | |
| G6PD Intermediate or Heterozygous Volunteers | * Subjects with age ≥ 18 years * Female * Previously tested G6PD intermediate or heterozygous for G6PD variants at SMRU clinic | |
| G6PD-Normal Volunteers | * Subjects with age ≥ 18 years * Male and female * Previously tested G6PD normal at SMRU clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation in G6PD activity
determined by the Biosensors and the spectrophotometric gold standard.
Measured: at enrollment
Secondary outcomes (2)
correlation in Hemoglobin levels
determined by the Biosensors and the automated blood analyzer.
Measured: at enrollment
Determine association between one or more quantitative POC G6PD test (Biosensor) and the flow cytometry-based G6PD test
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start24 Jan 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- PATH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625285
- Sponsor's protocol ID
- SMRU1501
- Acronym
- Biosensors
- Status last verified
- Feb 2018
- First submitted
- 4 Dec 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of New G6PD Point of Care Tests (Biosensors) Against Gold Standard Quantitative Spectrophotometry and Genotyping
- ClinicalTrials.gov ID
- NCT02625285
- Acronym / sponsor ID
- Biosensors / SMRU1501
- Conditions
- Validation, Biosensors, Genotyping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- PATH
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 9 Dec 2015 (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.
This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping.
Detailed description
Radical cure of P. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative G6PD tests. Different regimens of drug might be more appropriate in subjects with intermediate G6PD activity which can be currently measured only in well equipped laboratories. Validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against Plasmodium vivax.
This study will evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 G6PD-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 G6PD-heterozygous women with intermediate activity, and approximately 50 G6PD-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. The home visitor will explain study details and invite to participate in the study. If the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care.
After signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. The blood from capillary sample will be used to assess G6PD activity using the POC tests, CBC and laboratory based quantitative tests. The venous blood will be used for reference standard quantitative G6PD assays, Hb typing analysis, CBC and buffy-coat will be stored for DNA extraction for G6PD genotyping only; leftover blood will be discarded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G6PD Deficient Volunteers | – | –* Subjects with age ≥ 18 years * Male and female * Previously tested G6PD deficient at SMRU clinic |
| G6PD Intermediate or Heterozygous Volunteers | – | –* Subjects with age ≥ 18 years * Female * Previously tested G6PD intermediate or heterozygous for G6PD variants at SMRU clinic |
| G6PD-Normal Volunteers | – | –* Subjects with age ≥ 18 years * Male and female * Previously tested G6PD normal at SMRU clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The total sample size will be 150 patients, using targeted enrollment to achieve a convenience sample of approximately 50 G6PD deficient volunteers (male and female), approximately 50 G6PD intermediate or heterozygous female volunteers, and the remaining will be G6PD-normal volunteers with a 1:1 male/female ratio.
Key inclusion criteria (4 listed)
- Subjects with age ≥ 18 years
- Subjects willing to participate and sign informed consent form
- Male and Female
- Previously tested G6PD deficient, G6PD normal and G6PD intermediate or heterozygous for G6PD variants at SMRU clinic
Key exclusion criteria (4 listed)
- Patients with severe malaria or other severe or any acute 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)
- Patients who have not had a critical illness or received other hemolytic drugs (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.
Primary outcome
correlation in G6PD activity
Time frame: at enrollment
determined by the Biosensors and the spectrophotometric gold standard.
2 secondary outcomes
correlation in Hemoglobin levels
Time frame: at enrollment
Determine association between one or more quantitative POC G6PD test (Biosensor) and the flow cytometry-based G6PD test
Time frame: at enrollment
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 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation and Biosensors, run by University of Oxford 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 4 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 Feb 2018. 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 in G6PD activity (time frame: at enrollment). 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 Feb 2018.