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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of IPSE-Specific Nanobodies and Application in the Diagnosis of Schistosoma Haematobium Infection
- ClinicalTrials.gov ID
- NCT07500740
- Acronym / sponsor ID
- JIPD-2025-007
- Conditions
- Schistosomiasis Haematobia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Pemba Ministry of Health ZanzibarUniversity, hospital or other
- Collaborators
- Jiangsu Institute of Parasitic Diseases
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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.
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Schistosomiasis Haematobia
Not yet recruitingObservational study
Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
Schistosoma Haematobium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis Haematobia, run by Pemba Ministry of Health Zanzibar at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.