Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-29 @ 7:45 PM
Study NCT ID:
NCT02666092
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anisakis Blastocystis Cryptosporidium Fish Serology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D017129', 'term': 'Anisakiasis'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017191', 'term': 'Ascaridida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis', 'timeFrame': 'contact by phone during 30 min at only visit (inclusion)', 'description': 'comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.'}], 'secondaryOutcomes': [{'measure': 'anti-Anisakis and/or anti-fish IgE level by serum analysis', 'timeFrame': 'contact by phone during 30 min at only visit (inclusion)', 'description': 'Comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.'}, {'measure': 'the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis', 'timeFrame': 'contact by phone during 30 min at only visit (inclusion)'}, {'measure': 'nomber of subjects of previous Anisakidae infections', 'timeFrame': 'contact by phone during 30 min at only visit (inclusion)', 'description': 'questionnaire-based diagnosis, supported by serological testing between patients with fish allergy and a matched control population, presenting no fish allergy.'}, {'measure': 'Measure of the performances of serological tests', 'timeFrame': 'at work medical visit (inclusion)', 'description': 'Comparison of the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection.'}, {'measure': 'The frequency of domestic exposure to fish parasites antigens by questionnaire', 'timeFrame': 'contact by phone during 30 min at only visit (inclusion)', 'description': 'It will be compared between Anisakis or fish allergic/sensitized subjects and non-allergic/non sensitized subjects.\n\nIt will be compared between patients with or without previous Anisakidosis. Fish exposure will be determined taking into account the handled fish species and the local prevalences of fish parasites.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IgE', 'Immunoelectrophoresis', 'Western Blot', 'ImmunoCAP'], 'conditions': ['Allergy to Fish', 'Allergy', 'Anisakis']}, 'descriptionModule': {'briefSummary': 'Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic diseases agents, and have a high impact on human health.\n\nInfestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or cooked fish, and may masquerade as fish allergy.\n\nIn this study, we aim to characterize the relationship between Anisakidae and/or fish sensitization and the presence of allergic manifestations in patients recruited in the general population and presenting fish allergy resulting from ingestion, cutaneous or respiratory contact. We will also determine the respective role of Anisakidae or fish sensitization in patients with fish allergy. Then, we will determine the prevalence of previous Anisakidae infections among these patients and a matched control population. We will also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).', 'detailedDescription': 'First, 51 patients with fish allergy will be recruited from the Parasitology-Mycology and Immunology Laboratories of Lille University Hospital databases (serology for anti-Anisakis or anti-fish detection). Then, clinical (characteristics of allergic manifestations) and epidemiological (domestic exposure to fish) data will be collected, and anti-fish or Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), or ImmunoCAP, immunoelectrophoresis, Western Blot, respectively. Similar serological tests will be performed for a control group of 51 matched subjects who will be recruited among Lille University Hospital workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruited population will include:\n\n* 51 patients with fish allergy\n* 51 matched control subjects (sex, age +/- 5 years)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nALLERGIC PATIENTS:\n\n* Previous serological assessment for anti-Anisakis or anti-fish antibodies detection (ImmunoCap and/or immunoelectrophoresis) in Lille University Hospital Center, and volume of serum conserved ≥500 µl\n* Allergic manifestations after contact with fish (asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, eosinophilic gastroenteritis, gingivostomatitis, angioedema, bronchospasm, anaphylaxis)\n\nCONTROL SUBJECTS:\n\n* Serological assessment for infectious disease during a routine occupational health consultation in Lille University Hospital Center\n* Absence of fish allergy\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding female\n* Patient with no social insurance\n* Patient unwilling to comply with the protocol\n* Patient unable to understand the study and its objectives\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT02666092', 'acronym': 'ABCFish2', 'briefTitle': 'Anisakis Blastocystis Cryptosporidium Fish Serology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Role of Anisakidae and/or Fish Flesh Antigens in Fish Allergies.', 'orgStudyIdInfo': {'id': '2013_43'}, 'secondaryIdInfos': [{'id': '2014-A00855-42', 'type': 'OTHER', 'domain': 'ID RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fish allergy', 'description': '51 subjects presenting allergic manifestations after digestive, cutaneous, or respiratory contact with fish will be recruited.\n\nInterventions will include:\n\n* A questionnaire on domestic exposure to fish, and on the characteristics of clinical manifestations\n* A detection of anti-Anisakis and anti-fish antibodies', 'interventionNames': ['Other: Questionnaire', 'Biological: Detection of anti-Anisakis and anti-fish antibodies']}, {'label': 'Control', 'description': '51 subjects presenting no allergic manifestations after contact with fish.\n\nInterventions will include:\n\n* A questionnaire on domestic exposure to fish\n* A detection of anti-Anisakis and anti-fish antibodies', 'interventionNames': ['Other: Questionnaire', 'Biological: Detection of anti-Anisakis and anti-fish antibodies']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)', 'armGroupLabels': ['Control', 'Fish allergy']}, {'name': 'Detection of anti-Anisakis and anti-fish antibodies', 'type': 'BIOLOGICAL', 'description': 'Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.', 'armGroupLabels': ['Control', 'Fish allergy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Emmanuel DUTOIT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, {'name': 'ANSES', 'class': 'OTHER'}, {'name': 'Hôpital Cochin', 'class': 'OTHER'}, {'name': 'Région Nord-Pas de Calais, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}