Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT05506358
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2022-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sickle cell disease (SCD) is an inherited blood disorder associated with acute illness and organ damage. In high resource settings, early screening and treatment greatly improve quality of life. In low resource settings, however, mortality rate for children is high (50-90%). Low-cost and accurate screening techniques are critical to reducing the burden of the disease, especially in remote/rural settings. The most common and severe form of SCD is sickle cell anemia (SCA), caused by the inheritance of genes causing abnormal forms of hemoglobin (called sickle hemoglobin or hemoglobin S) from both parents. The asymptomatic or carrier form of the disease, known as sickle cell trait (SCT), is caused by the inheritance of only one variant gene from one of the parents. In areas such as Nepal, β-thalassemia (another inherited blood disorder) and SCD are both prevalent, and some combinations of these diseases lead to severe symptoms.
The purpose of this study is to determine the accuracy of low-cost point-of-care techniques for screening and detecting sickle cell disease, sickle cell trait, and β-thalassaemia, which will subsequently inform on feasible solutions for detecting the disease in rural, remote, or low-resource settings. One of the goals of the study is to evaluate the feasibility of techniques, such as the sickling test with low-cost microscopy and machine learning, HbS solubility test, commercial lateral-flow assays (HemoTypeSC and Sickle SCAN), and the Gazelle Hb variant test, to supplement or replace gold standard tests (HPLC or electrophoresis), which are expensive, require highly trained personnel, and are not easily accessible in remote/rural settings.
The investigators hypothesize that:
1. an automated sickling test (standard sickling test enhanced using low-cost microscopy and machine learning) has a higher overall accuracy than conventional screening techniques (solubility and sickling tests) to detect hemoglobin S in blood samples
2. the automated sickling test can additionally classify SCD, SCT and healthy individuals with a sensitivity greater than 90%, based on morphology changes of red blood cells, unlike conventional sickling or solubility tests that do not distinguish between SCD and SCT cases
3. Gazelle diagnostic device can detect β-thalassaemia and SCD/SCT with an overall accuracy greater than 90%, compared with HPLC as the reference test
The purpose of this study is to determine the accuracy of low-cost point-of-care techniques for screening and detecting sickle cell disease, sickle cell trait, and β-thalassaemia, which will subsequently inform on feasible solutions for detecting the disease in rural, remote, or low-resource settings. One of the goals of the study is to evaluate the feasibility of techniques, such as the sickling test with low-cost microscopy and machine learning, HbS solubility test, commercial lateral-flow assays (HemoTypeSC and Sickle SCAN), and the Gazelle Hb variant test, to supplement or replace gold standard tests (HPLC or electrophoresis), which are expensive, require highly trained personnel, and are not easily accessible in remote/rural settings.
The investigators hypothesize that:
1. an automated sickling test (standard sickling test enhanced using low-cost microscopy and machine learning) has a higher overall accuracy than conventional screening techniques (solubility and sickling tests) to detect hemoglobin S in blood samples
2. the automated sickling test can additionally classify SCD, SCT and healthy individuals with a sensitivity greater than 90%, based on morphology changes of red blood cells, unlike conventional sickling or solubility tests that do not distinguish between SCD and SCT cases
3. Gazelle diagnostic device can detect β-thalassaemia and SCD/SCT with an overall accuracy greater than 90%, compared with HPLC as the reference test
Detailed Description:
Overall, the hypothesis is that an assessment of the performance and accuracies of low-cost point-of-care techniques (automated sickling test, solubility test, lateral-flow assays, Gazelle Hb variant test) against HPLC tests will provide researchers and health workers with feasible alternative options for screening and detecting SCD, SCT and β-thalassaemia in a variety of situations based on the needs of the communities and the resources available.
Objectives
Objectives specific to the current study are to:
1. Determine accuracy (sensitivity and specificity) of automated sickling test to detect HbS, compared to gold standard HPLC, and to conventional solubility test
2. Determine whether SCD, SCT and healthy individuals can be classified using the automated sickling test that leverages machine learning on images of blood films under hypoxia
3. Validate accuracy (\>95% sensitivity and specificity) of lateral- flow assays (HemoTypeSC and Sickle SCAN) to detect SCD/SCT, and of Gazelle variant test to detect SCD, SCT, and β-thalassaemia; and determine if low-cost techniques can potentially replace HPLC/electrophoresis tests in rural and remote settings
Long-term objectives of the overall project are to:
1. Implement trained machine learning algorithm to classify SCD, SCT and healthy individuals during screening tests in Nepal
2. Implement relevant low-cost point-of-care techniques in rural and remote communities of Nepal using insights and conclusions from current study
The plan of the study to screen the communities (e.g. in Nepalgunj, in Vancouver) using the following:
a. Low-cost screening i. Sickling test with low-cost microscope and automated screening with machine learning ii. Sickling test with traditional microscope (conventional manual screening used in Nepal) iii. HbS solubility test iv. Commercial point-of-care assays (HemoTypeSC and Sickle SCAN) v. Gazelle Hb variant test b. Gold standard test: HPLC, for determining the accuracies of low-cost screening techniques
De-identified data (images of blood films and associated documentation) will also be deposited in an online public repository, such as the Federated Research Data Repository (FRDR). FRDR is a service of the Digital Research Alliance of Canada (Alliance), a not-for-profit organization that supports digital research infrastructure in Canada. FRDR is hosted on national infrastructure, managed and administered by the Digital Research Alliance of Canada.
Objectives
Objectives specific to the current study are to:
1. Determine accuracy (sensitivity and specificity) of automated sickling test to detect HbS, compared to gold standard HPLC, and to conventional solubility test
2. Determine whether SCD, SCT and healthy individuals can be classified using the automated sickling test that leverages machine learning on images of blood films under hypoxia
3. Validate accuracy (\>95% sensitivity and specificity) of lateral- flow assays (HemoTypeSC and Sickle SCAN) to detect SCD/SCT, and of Gazelle variant test to detect SCD, SCT, and β-thalassaemia; and determine if low-cost techniques can potentially replace HPLC/electrophoresis tests in rural and remote settings
Long-term objectives of the overall project are to:
1. Implement trained machine learning algorithm to classify SCD, SCT and healthy individuals during screening tests in Nepal
2. Implement relevant low-cost point-of-care techniques in rural and remote communities of Nepal using insights and conclusions from current study
The plan of the study to screen the communities (e.g. in Nepalgunj, in Vancouver) using the following:
a. Low-cost screening i. Sickling test with low-cost microscope and automated screening with machine learning ii. Sickling test with traditional microscope (conventional manual screening used in Nepal) iii. HbS solubility test iv. Commercial point-of-care assays (HemoTypeSC and Sickle SCAN) v. Gazelle Hb variant test b. Gold standard test: HPLC, for determining the accuracies of low-cost screening techniques
De-identified data (images of blood films and associated documentation) will also be deposited in an online public repository, such as the Federated Research Data Repository (FRDR). FRDR is a service of the Digital Research Alliance of Canada (Alliance), a not-for-profit organization that supports digital research infrastructure in Canada. FRDR is hosted on national infrastructure, managed and administered by the Digital Research Alliance of Canada.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: