Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT07171658
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation to Cervical Cancer Screening (CCS)', 'timeFrame': '12 months', 'description': 'Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %'}], 'secondaryOutcomes': [{'measure': 'Correlation of socio-demographic characteristics with screening participation', 'timeFrame': '12 months', 'description': 'Regression coefficients of screening in the past 12 months for: education level, occupation, relationship status, sexual orientation, mother tongue, country of origin, residential area, children, follow-up by general practitioner or gynecologist, age, number of years living in Switzerland, Body Mass Index (calculated based on weight and height).\n\nMeasurement tool: self-reported from questionnaire'}, {'measure': 'Choice of primary screening methods (HPV testing vs cytology)', 'timeFrame': '12 months', 'description': 'Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm.'}, {'measure': 'Prevalence of positive primary screening (HPS test) and triage results (cytology)', 'timeFrame': '12 months', 'description': 'Difference between study arms of the:\n\n* Prevalence of screen-positive women (i.e. HPV-positive or Atypical squamous cells of undetermined significance - ASC-US+)\n* Proportion (%) of HPV-positive women with ASC-US+ upon triage\n* Proportion (%) of Cervical Intraepithelial Neoplasia Grade 2 (CIN2+) diagnosed\n* Proportion (%) of Cervical Cancer (CC) diagnosed\n* Proportion (%) of participants treated for CIN2+ or CC'}, {'measure': 'Follow-up rates for participants screened positive', 'timeFrame': '12 months', 'description': 'Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage'}, {'measure': 'Acceptability of screening strategies', 'timeFrame': '12 months', 'description': 'Difference between study arms of the:\n\n\\- Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied)'}, {'measure': 'Reasons for non-compliance', 'timeFrame': '12 months', 'description': 'Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance'}, {'measure': 'Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors', 'timeFrame': '12 months', 'description': 'Difference in the study arms: of the proportion (%) of participants having done all screenings, and participants having selected only one or two screenings, and participants having done none.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer screening', 'underscreened women', 'HPV self-sampling', 'Integrated approach'], 'conditions': ['Cervical Cancer Screening']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland.\n\nThis randomized trial will compare three arms:\n\n1. Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.\n2. Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection\n3. Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.', 'detailedDescription': 'Secondary objectives are:\n\n* To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design).\n* To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms.\n* To compare prevalence of positive primary screening and triage results between study arms.\n* To compare follow-up rates for participants screened positive in both intervention arms.\n* To evaluate acceptability of both screening strategies (sensitization vs. home-based).\n* To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)\n* Aged 50 to 74 years old\n* Not been screened for cervical cancer in the past three years\n* Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)\n\nExclusion Criteria:\n\n* Prior cervical cancer diagnosis,\n* Hysterectomy\n* Non consent to participate to the study\n* Incapable of judgment or under tutelage\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07171658', 'acronym': 'BRAICS', 'briefTitle': 'Breast Cancer-Related Approach for Increasing Cervical Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'School of Health Sciences Geneva'}, 'officialTitle': 'Improving Cervical Cancer Screening Coverage Among Underscreened Women Aged 50 to 74 in Switzerland Using HPV Self-sampling Strategies: A Randomized Study - Breast Cancer-Related Approach for Increasing Cervical Cancer Screening', 'orgStudyIdInfo': {'id': '32HW-0_228666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group 1: Sensitization to Cervical Cancer (CC) screening', 'description': 'Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.', 'interventionNames': ['Behavioral: Sensitization to Cervical Cancer (CC) screening']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group 2: Home-based HPV self-sampling', 'description': 'Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.', 'interventionNames': ['Behavioral: Home-based HPV self-sampling']}], 'interventions': [{'name': 'Sensitization to Cervical Cancer (CC) screening', 'type': 'BEHAVIORAL', 'description': 'Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.', 'armGroupLabels': ['Intervention Group 1: Sensitization to Cervical Cancer (CC) screening']}, {'name': 'Home-based HPV self-sampling', 'type': 'BEHAVIORAL', 'description': 'Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.', 'armGroupLabels': ['Intervention Group 2: Home-based HPV self-sampling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Patrick Petignat, MD', 'role': 'CONTACT', 'email': 'patrick.petignat@hug.ch', 'phone': '+41 22 372 44 32'}], 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Jessica Di Vincenzo-Sormani, PhD', 'role': 'CONTACT', 'email': 'jessica.di-vincenzo-sormani@hesge.ch', 'phone': '+41 22 558 58 78'}, {'name': 'Patrick Petignat, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jessica Di Vincenzo Sormani, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haute École de Santé de Genève (HEdS-GE)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessica Di Vincenzo Sormani', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor assistant (tenure track)', 'investigatorFullName': 'Jessica Di Vincenzo Sormani', 'investigatorAffiliation': 'School of Health Sciences Geneva'}}}}