Schistosomiasis HaematobiaNCT07500740
Nanobody-based Schistosomiasis Urine Test Kit Research
An observational study of Schistosomiasis Haematobia, run by Pemba Ministry of Health Zanzibar at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schistosomiasis Haematobia
- What is being tested?
- Because this is an observational study, participants are not assigned an intervention as part of the study.
- How many people
- 2,500 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: A total of 2500 urine samples will be collected. These samples will be divided into five groups, each consisting of 500 individuals: Healthy control group; Schistosoma haematobium infection group; Schistosoma mansoni infection group; Nephritis patient group; Urinary tract infection patient group.
Who may be able to join
- 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
- 1) Index assay: nanobody-based lateral flow chromatography; 2) Reference assay: urine filtration microscopy; 3) Stool Kato-Katz examination if clinically indicated. 3. Complete basic demographic and clinical data (including age, sex, presenting symptoms, medical history, etc.) are available, and the participant has consented to the use of these data for study analysis.
- 4. Participants must fulfill one of the following group definitions:
- 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.
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- 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.
Who cannot join
- Participant did not provide written informed consent or was unable to complete the informed consent process.
- Participant is unable to provide a qualified specimen as required:
- 1) Unable to provide first morning midstream urine; 2) Urine volume < 30 mL; 3) Specimen is obviously contaminated, improperly preserved, or lacks complete labeling; 4) Index assay or reference assay cannot be completed, or results are uninterpretable.
- 3. Clinical or laboratory data are insufficient to allow for group assignment or subsequent study analysis.
- 4. Presence of any condition that may significantly interfere with the interpretation of study results (as assessed by the investigator or clinician), including:
- 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).
- 5. In the investigator's judgment, the participant is otherwise unsuitable for enrollment or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania1 site
Neglected tropical diseases in Pemba
Pemba, CharkChark, P.O.BOX 98
About this study
Official title: Screening of IPSE-Specific Nanobodies and Application in the Diagnosis of Schistosoma Haematobium Infection
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.
- Conditions
- Schistosomiasis Haematobia
- Being tested
- Because this is an observational study, participants are not assigned an intervention as part of the study.
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Because this is an observational study, participants are not assigned an intervention as part of the study.Other
Because this is an observational study, participants are not assigned an intervention as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, will be evaluated using urine filtration microscopy as the reference standard. Each participant will provide one urine sample at enrollment, and LFIA testing will be performed immediately after sample collection. Diagnostic performance will be assessed based on results obtained at this single time point.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosomiasis HaematobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pemba Ministry of Health Zanzibar
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Institute of Parasitic Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500740
- Sponsor's protocol ID
- JIPD-2025-007
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided