Glucose-6-Phosphate Dehydrogenase DeficiencyNCT02104518
Evaluation of Different G6PD Testing Platforms
An observational study of Glucose-6-Phosphate Dehydrogenase Deficiency, run by PATH at 1 site in Indonesia.
Trial summary
In this study the investigators propose to evaluate the performance of several G6PD testing platforms. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose-6-Phosphate Dehydrogenase Deficiency
- How many people
- 700 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2014to Jun 2014
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.
Who may be able to join
- Subjects must be at least five years of age
- Patient / parental consent
- Patient willing to allow donated sample to be used in future research
Who cannot join
- Patients with severe malaria or other severe illness
- Patients who received a blood transfusion in the last three months
- Patients unwilling to allow donated blood to be used in future research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Point-of-care G6PD Diagnostic Test
In this study the investigators propose to evaluate the performance of several G6PD testing platforms.
Read the detailed description
In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.
- Keywords
- glucose-6-phosphate dehydrogenase, point-of-care diagnostic testing
- 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.
| Study group | Role | What they receive |
|---|---|---|
| G6PD testing | Blood samples will be tested for G6PD activity levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine concordance between point-of-care tests and spectrophotometric gold standard
Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.
Measured: Six months
Secondary outcomes (4)
Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard
This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard.
Measured: Six months
Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard
Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
Measured: Six months
Determine concordance between point-of-care G6PD tests and the florescent spot test
Compare sensitivity \& specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.
Measured: Six months
Define the G6PD-normal and deficient profiles in the SW Sumba population.
Determine the profile of the SW Sumba area in regards to normal and deficient population spread.
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 posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Eijkman Institute for Molecular Biology
- Responsible party
- Sponsor
- Investigators
- Ari Winasti Satyagraha, PhD, Study chair, Eijkman Institute for Molecular BiologyKevin Baird, PhD, Study chair, Oxford University Clinical Research Unit Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104518
- Sponsor's protocol ID
- Eijkman-69
- Status last verified
- Oct 2014
- First submitted
- 1 Apr 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Point-of-care G6PD Diagnostic Test
- ClinicalTrials.gov ID
- NCT02104518
- Acronym / sponsor ID
- Eijkman-69
- Keywords
- glucose-6-phosphate dehydrogenase, point-of-care diagnostic testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Eijkman Institute for Molecular Biology
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Apr 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 the investigators propose to evaluate the performance of several G6PD testing platforms.
Detailed description
In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G6PD testing | – | –Blood samples will be tested for G6PD activity levels |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.
Key inclusion criteria (3 listed)
- Subjects must be at least five years of age
- Patient / parental consent
- Patient willing to allow donated sample to be used in future research
Key exclusion criteria (3 listed)
- Patients with severe malaria or other severe illness
- Patients who received a blood transfusion in the last three months
- Patients unwilling to allow donated blood to be used in future research
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
Determine concordance between point-of-care tests and spectrophotometric gold standard
Time frame: Six months
Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.
4 secondary outcomes
Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard
Time frame: Six months
Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard
Time frame: Six months
Determine concordance between point-of-care G6PD tests and the florescent spot test
Time frame: Six months
Define the G6PD-normal and deficient profiles in the SW Sumba population.
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 28 Oct 2014.
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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.
Ari Winasti Satyagraha, PhD study chair
Eijkman Institute for Molecular Biology
Kevin Baird, PhD study chair
Oxford University Clinical Research Unit Indonesia
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 Glucose-6-Phosphate Dehydrogenase Deficiency, run by PATH at 1 site in Indonesia.
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 3 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 28 Oct 2014. 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 Indonesia. 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?
Determine concordance between point-of-care tests and spectrophotometric gold standard (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 28 Oct 2014.