Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-03-03 @ 12:39 AM
Study NCT ID:
NCT06343103
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Occupational Exposure to Antineoplastic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the difference in micronuclei frequency', 'timeFrame': '1 year', 'description': 'Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytotoxicity']}, 'descriptionModule': {'briefSummary': 'The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).\n\nThe control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics.', 'detailedDescription': 'The study will be proposed to all workers exposed to cytotoxic agents who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol. Participation of workers in the study is voluntary.\n\nThe control group will be recruited from administrative staff and/or individuals not exposed to chemotherapy who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol.\n\nA subject is considered enrolled after signing the informed consent and will be considered evaluable if:\n\nThey have completed the exposure diary (only for the exposed group). They have responded to the medical history questionnaire. They have undergone sampling of oral mucosa exfoliated cells and blood collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Capacity to understand and consent\n* Personnel with an employment contract or similar arrangement\n* Ability to comply with the procedures outlined in the protocol\n* Signing of the informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Any ongoing chemotherapy or radiation treatment for neoplasms of any kind\n* Planned diagnostic exams involving radiation within three weeks following the signing of the Informed Consent\n* Inability to comply with the procedures outlined in the protocol'}, 'identificationModule': {'nctId': 'NCT06343103', 'acronym': 'BRIC', 'briefTitle': 'Study Evaluating Occupational Exposure to Antineoplastic Drugs', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring', 'orgStudyIdInfo': {'id': 'IEO 1735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Workers exposed', 'description': 'Workers exposed to cytotoxic agents', 'interventionNames': ['Other: Workers exposed']}, {'type': 'OTHER', 'label': 'Workers not exposed', 'description': 'Workers not exposed to cytotoxic agents', 'interventionNames': ['Other: Workers not exposed']}], 'interventions': [{'name': 'Workers exposed', 'type': 'OTHER', 'description': 'Workers exposed to cytotoxic agents', 'armGroupLabels': ['Workers exposed']}, {'name': 'Workers not exposed', 'type': 'OTHER', 'description': 'Workers not exposed to cytotoxic agents', 'armGroupLabels': ['Workers not exposed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabrina Beltramini', 'role': 'CONTACT'}], 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuela Omodeo Salè', 'role': 'CONTACT'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piera Maiolino', 'role': 'CONTACT'}], 'facility': 'Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicoletta Rigamonti', 'role': 'CONTACT'}], 'facility': 'Istituto Oncologico Veneto Irccs', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Di Mattia', 'role': 'CONTACT'}], 'facility': 'Fondazione Policlinico Universitario Campus Bio-Medico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Emanuela Omodeo Salè', 'role': 'CONTACT', 'email': 'eomodeo@ieo.it', 'phone': '+39 02 57489051'}], 'overallOfficials': [{'name': 'Emanuela Omodeo Salè', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}