Nanobody-based Schistosomiasis Urine Test Kit Research (NCT07500740) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Nanobody-based Schistosomiasis Urine Test Kit Research
Tanzania2,500 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. Signed written informed consent must be obtained from the participant. If the participant is a minor or legally incompetent, written informed consent must be obtained from the parent(s) or legal guardian, together with assent from the participant where applicable.
✓. Able to provide a 30-50 mL first-morning midstream urine sample as required and willing to comply with all study-specified procedures, including
✓. S. haematobium infection group: Schistosoma haematobium eggs detected by urine filtration microscopy, with ≥1 egg per 10 mL urine.
✓. S. mansoni infection group: Schistosoma mansoni eggs detected in stool by Kato-Katz thick smear.
✓. Nephritis group: Clinical diagnosis of nephritis supported by abnormal urinalysis (e.g., proteinuria).
✓. Urinary tract infection (UTI) group: Clinical diagnosis of urinary tract infection supported by abnormal urinalysis (e.g., leukocyturia, bacteriuria).
✓. Healthy control group: Negative parasitological test results and no clinical evidence of the aforementioned diseases.
Exclusion criteria
✕. Participant did not provide written informed consent or was unable to complete the informed consent process.
What they're measuring
1
Diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, using urine filtration microscopy as the reference method.
Timeframe: At baseline (Day 1), at the time of participant enrollment and urine sample collection, with LFIA testing performed immediately. Diagnostic performance will be assessed based on results obtained at this single time point. The study will commence in April
. Participant is unable to provide a qualified specimen as required:
✕. Other concurrent, clearly defined severe urinary tract diseases or acute/critical illnesses that preclude differentiation of the cause of abnormal urinalysis parameters;
✕. Recent treatment that may affect parasitological or urinalysis results (e.g., recent antiparasitic therapy, antibiotic therapy, etc.), potentially leading to unreliable group assignment (specific time windows may be defined in the protocol).