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NOT YET RECRUITING
NCT07500740

Nanobody-based Schistosomiasis Urine Test Kit Research

Sponsor: Pemba Ministry of Health Zanzibar

View on ClinicalTrials.gov

Summary

This study aims to develop and evaluate a nanobody-based urine diagnostic test for Schistosoma haematobium infection through IPSE antigen detection. Approximately 2500 participants will be recruited and divided into five groups: confirmed S. haematobium infection, S. mansoni infection, urinary tract infection, nephritis or other renal diseases, and healthy controls (about 500 individuals per group). Each participant will provide a single morning midstream urine sample (30-50 mL), which will be used both for the development and optimization of the nanobody-based colloidal gold lateral flow assay (LFIA) and for evaluation of its diagnostic performance compared with urine-filtration microscopy.

Official title: Screening of IPSE-Specific Nanobodies and Application in the Diagnosis of Schistosoma Haematobium Infection

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2500

Start Date

2026-04-01

Completion Date

2026-12-01

Last Updated

2026-03-30

Healthy Volunteers

Not specified

Interventions

OTHER

Because this is an observational study, participants are not assigned an intervention as part of the study.

Because this is an observational study, participants are not assigned an intervention as part of the study.

Locations (1)

Neglected tropical diseases in Pemba

Pemba, CharkChark, Tanzania