Trial record 3 of 17 for:    "glucose-6-phosphate dehydrogenase deficiency"

Evaluation of Different G6PD Testing Platforms

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by PATH
Sponsor:
Collaborator:
Eijkman Institute of Molecular Biology
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT02104518
First received: April 1, 2014
Last updated: April 3, 2014
Last verified: March 2014
  Purpose

In this study the investigators propose to evaluate the performance of several G6PD testing platforms.


Condition
Glucose-6-Phosphate Dehydrogenase Deficiency

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Evaluation of a Point-of-care G6PD Diagnostic Test

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Determine concordance between point-of-care tests and spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.


Secondary Outcome Measures:
  • Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]
    This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard.

  • Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard

  • Determine concordance between point-of-care G6PD tests and the florescent spot test [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.

  • Define the G6PD-normal and deficient profiles in the SW Sumba population. [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Determine the profile of the SW Sumba area in regards to normal and deficient population spread.


Biospecimen Retention:   Samples With DNA

Left-over venous blood will be spun down and buffy coat and extracted DNA will be stored in labeled tubes for later G6PD genotyping and characterization.


Estimated Enrollment: 700
Study Start Date: September 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
G6PD testing
Blood samples will be tested for G6PD activity levels

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Subjects must be at least five years of age
  • Patient / parental consent
  • Patient willing to allow donated sample to be used in future research

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104518

Contacts
Contact: Jake Abrahams, BA 206.302.4743 jabrahams@path.org

Locations
Indonesia
Eijkman Institute for Molecular Biology Not yet recruiting
Jakarta, Indonesia
Sponsors and Collaborators
PATH
Eijkman Institute of Molecular Biology
Investigators
Study Chair: Ari Winasti Satyagraha, PhD Eijkman Institute for Molecular Biology
Study Chair: Kevin Baird, PhD Eijkman Oxford Clinical Research Unit
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02104518     History of Changes
Other Study ID Numbers: Eijkman-69
Study First Received: April 1, 2014
Last Updated: April 3, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by PATH:
glucose-6-phosphate dehydrogenase
point-of-care diagnostic testing

Additional relevant MeSH terms:
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014