Evaluation of Different G6PD Testing Platforms

NCT02104518 | Completed DMC

• 1 other identifier: Eijkman-69
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glucose-6-Phosphate Dehydrogenase Deficiency

Keywords

glucose-6-phosphate dehydrogenase; point-of-care diagnostic testing

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months

Secondary Outcomes (4)

• Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard

  Six months

• Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard

  Six months

• Determine concordance between point-of-care G6PD tests and the florescent spot test

  Six months

• Define the G6PD-normal and deficient profiles in the SW Sumba population.

  Six months

Study Arms (1)

G6PD testing

Blood samples will be tested for G6PD activity levels

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• PATH: lead
• Eijkman Institute for Molecular Biology: collaborator

Study Sites (1)

Eijkman Institute for Molecular Biology

Jakarta, Indonesia

Location

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.

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ari Winasti Satyagraha, PhD

  Eijkman Institute for Molecular Biology

  STUDY CHAIR

• Kevin Baird, PhD

  Oxford University Clinical Research Unit Indonesia

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

ID (1)