An interventional study of UCP-LF CAA assay in Schistosomiasis, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 8 sites in 5 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Diagnostic
The primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, PCR (where available), POC-CCA (where available), and serum CAA results).
All subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome PCR where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and Schistosome PCR (where available), and urine strip testing POC-CCA (where available); and stool sampling for microscopy and PCR, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity.
Composite reference standards will be used to assess and classify the activity of the infection. Organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected.
Serum (at least 1 ml remaining from routine diagnostics) will be sent to LUMC, the Netherlands, where CAA will be determined with the UCP-LF CAA test designed for routine use.
Participants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at LUMC for 15 years, to allow secondary research.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's planned enrollment of 278 is close to the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All eligible participants identified as having chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory assessment at enrollment that will include blood sampling for hematology, Schistosoma serology available at each site, and PCR for Schistosoma where available; urine sampling for microscopy, determination of hematuria as indirect markers of schistosomiasis morbidity, and Schistosoma PCR (where available) and POC-CCA urine strip assay (where available); and stool sampling for microscopy and PCR where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Serum (at least 1 mL leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA will be determined with the UCP-LF CAA assay (dry format) designed for routine use.
Device: UCP-LF CAA assay
dry LF-CAA, or CAA
Active infection
Proportion of enrolled participants fulfilling the composite reference standards for active infection: * Microscopy (Positive/Negative) * PCR (Positive/Negative, if performed) * CAA (Positive/Negative) * Serology (Positive/Negative)
Time frame: Baseline
CAA result
Number of enrolled participants with positive CAA result at inclusion compared to number of those fulfilling the composite reference standards active infection and of those positive by each separate diagnostic method * Microscopy (P/N) * PCR (P/N) * CAA (P/N) * Serology (P/N) * POC-CCA (P/N) * Signs/symptoms (eosinophilia (Y/N; eos/μL), hematuria (Y/N), fecal occult blood (Y/N), bladder mucosal lesions (Y/N, if ultrasound performed)
Time frame: Baseline
CAA cure
Number of participants who will be CAA negative at week 6 post-treatment compared to number of participants fulfilling the definitions of cure and to number of negative results by each other separate diagnostic method. * Microscopy - viable eggs (P/N) * CAA (P/N) * Signs/symptoms (eosinophilia (Y/N; eos/μL), hematuria (Y/N), fecal occult blood (Y/N)
Time frame: At week 6 post-treatment
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IRCCS Sacro Cuore Don Calabria di Negrar