KAKADU
A Comprehensive Evaluation of an Artificial Intelligence Based Digital Pathology to Monitor Large-scale Deworming Programs Against Soil-transmitted Helminths
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Johnson & Johnson Foundation
observational
1,100
0 countries
N/A
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this observational study is to test a new AI diagnostic tool for detection, specification and quantification of parasitic infections (Ascaris, Trichuris, hookworm and S. Mansoni) in School aged children in Ethiopia and Uganda. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2023
Actual (reported)September 26, 2023
Actual (reported)October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diagnostic performance, P1.1-2
the clinical sensitivity of Kato-Katz 2.0 (KK2.0) and Kato-Katz 1.0 (KK1.0) to detect low, moderate and heavy intensity infections of Ascaris, Trichuris and hookworms
up to 10 months
Diagnostic Performance P1.3-4
The clinical specificity of Kato-Katz 2.0 (KK2.0) and Kato-Katz 1.0 (KK1.0) to detect low, moderate and heavy intensity infections of Ascaris, Trichuris and hookworms
up to 10 months
Repeatability and Reproducibility Performance P2
The repeatability and the reproducibility of the scanning process, the AI verification process, the Kato-Katz 2.0 (KK2.0) system as a whole and the manual counting by a microscopist (Kato-Katz 1.0 (KK1.0)).
up to 10 months
Time to Result P3
Time to result for the artificial intelligence digital pathology diagnostic (Kato-Katz 2.0 (KK2.0)) result.
Diagnostic performance S1.1
up to 10 months
Diagnostic performance S1.2
up to 10 months
Diagnostic performance S1.3
up to 10 months
Diagnostic performance S1.4
up to 10 months
Repeatability and Reproducibility Performance S2.1
up to 10 months
A number of school aged children in Ethiopia from 5-7 different schools in the Jimma region.
A number of school aged children from Uganda. Children from 5-7 different schools will be in the group.
School aged children will be asked to leave a stool sample. The samples will be prepared with the Kato-Katz method and scanned and processed by an artificial intelligence digital pathology system to determine the infection level of soil transmitted helminths and schistosomiasis. The samples will also be analyzed by a human microscopist for comparison.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study will focus on SAC (age 5 - 14) only, since they are the major target of large-scale deworming programs against STHs. The investigators will apply the inclusion and exclusion criteria summarized above
Ward PK, Roose S, Ayana M, Broadfield LA, Dahlberg P, Kabatereine N, Kazienga A, Mekonnen Z, Nabatte B, Stuyver L, Velde FV, Hoecke SV, Levecke B. A comprehensive evaluation of an artificial intelligence based digital pathology to monitor large-scale deworming programs against soil-transmitted helminths: A study protocol. PLoS One. 2024 Oct 28;19(10):e0309816. doi: 10.1371/journal.pone.0309816. eCollection 2024.
Bruno Levecke, PhD
University Ghent
Zeleke Mekonnen, PhD
Jimma University
Narcis Kabatereine, PhD
Ministry of Health, Uganda
First Submitted
September 15, 2023
First Posted
September 26, 2023
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Single-sex Female Controlled Human Schistosomiasis Mansoni Infection
up to 10 months
Cost Efficiency P4.1
The total survey cost to reliably inform a stop decision to the program for Kato-Katz 2.0 (KK2.0) and Kato-Katz 1.0 (KK1.0).
up to 10 months
Cost Efficiency P4.2
The total survey cost to reliably inform a declaration that STH are eliminated as a public health problem for Kato-Katz 2.0 (KK2.0) and Kato-Katz 1.0 (KK1.0).
up to 10 months
Usability observation P5
The ease-of-use of the complete AI-DP work process for the identified end-users assessed by observations of user groups and user interviews.
up to 10 months
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2023
Record last verified: 2023-09
The investigators do not intend to share individual participant data (IPD).
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Source: ClinicalTrials.gov.
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