Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-24 @ 10:19 AM
Study NCT ID:
NCT02194712
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012552', 'term': 'Schistosomiasis'}], 'ancestors': [{'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, urine and faeces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of UCP-CAA', 'timeFrame': '12 weeks after last water contact', 'description': 'The diagnostic performance of UCP-CAA will be assessed by calculating the sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact. Routine diagnostics performed by the individual centers, such as serology, will be the standard against which sensitivity (number of cases positive in both tests / number of cases positive in routine diagnostics) and specificity (number of cases negative in both tests / number of cases negative in routine diagnostics) is calculated.'}], 'secondaryOutcomes': [{'measure': 'The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment', 'timeFrame': 'six weeks after praziquantel treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['circulating anodic antigen'], 'conditions': ['Schistosomiasis']}, 'referencesModule': {'references': [{'pmid': '32307517', 'type': 'RESULT', 'citation': 'Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.'}]}, 'descriptionModule': {'briefSummary': 'Schistosomiasis is increasingly encountered among travellers returning from the tropics and is known for its focal endemicity, associated with the presence of the snail intermediate host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic due to the low intensity of infection, many infections likely go undiagnosed and will develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low burden infections, or serology, which is inadequate to monitor cure. The department of parasitology of the Leiden University Medical Center has developed a novel diagnostic test based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis infections and confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA in travellers with high-risk water contact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Travellers with reported high-risk water contact \\<12 weeks before inclusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any self-reported high risk water contact, including wading, showering, surfing, walking along wet shore bare-footed or washing with water from a high-risk source, within 12 weeks prior to reporting to the outpatient department\n2. Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection\n3. Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Previous treatment for schistosomiasis\n2. Known positive schistosomiasis serology\n3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology'}, 'identificationModule': {'nctId': 'NCT02194712', 'briefTitle': 'Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact', 'orgStudyIdInfo': {'id': 'CAA48780'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'travellers', 'description': 'travellers with recent (\\<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing', 'interventionNames': ['Other: Urine CAA detection']}], 'interventions': [{'name': 'Urine CAA detection', 'type': 'OTHER', 'description': 'In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.', 'armGroupLabels': ['travellers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100 DD', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3011 TG', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Harbour Hospital', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'M.P. Grobusch, Prof. MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'P.J.J. van Genderen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harbour Hospital Rotterdam'}, {'name': 'M. Roestenberg, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meta Roestenberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.Roestenberg, MD PhD', 'investigatorFullName': 'Meta Roestenberg', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}