Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-03 @ 2:38 AM
Study NCT ID:
NCT04114968
Status:
RECRUITING
Last Update Posted:
2020-11-06
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Offering Cervical Cancer Screening to Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation rate in the intervention group:', 'timeFrame': '1 year post invitation', 'description': 'Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling'}, {'measure': 'HPV prevalence', 'timeFrame': '1 year post invitation', 'description': 'Number of women tested positive for HPV'}, {'measure': 'Compliance to follow-up among HPV-positive self-samplers', 'timeFrame': '90 days post test results', 'description': 'The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral'}, {'measure': 'Screening history', 'timeFrame': 'Average of 10 years', 'description': 'Screening history of participants and non-participants in the intervention group'}, {'measure': 'Intervention versus control group:', 'timeFrame': '1 year post invitation', 'description': 'Participation rate'}, {'measure': 'Cytological findings', 'timeFrame': '1 year post invitation', 'description': 'Proportion of abnormal cytological findings between the intervention and control group is compared'}, {'measure': 'Histological findings', 'timeFrame': '1 year post invitation', 'description': 'Proportion of abnormal histological findings between the intervention and control group is compared'}, {'measure': 'Incidence', 'timeFrame': '5 year post invitation', 'description': 'The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group'}, {'measure': 'Mortality', 'timeFrame': '5 year post invitation', 'description': 'The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV self-sampling, cervical cancer screening in older women'], 'conditions': ['Uterine Cervical Neoplasm', 'Uterine Neoplasm', 'Uterine Cervical Disease', 'Mass Screening']}, 'referencesModule': {'references': [{'pmid': '37410699', 'type': 'DERIVED', 'citation': 'Tranberg M, Petersen LK, Hammer A, Elfstrom M, Blaakaer J, Jorgensen SF, Bennetsen MH, Jensen JS, Andersen B. Value of a catch-up HPV test in women aged 65 and above: A Danish population-based nonrandomized intervention study. PLoS Med. 2023 Jul 6;20(7):e1004253. doi: 10.1371/journal.pmed.1004253. eCollection 2023 Jul.'}, {'pmid': '33154056', 'type': 'DERIVED', 'citation': 'Tranberg M, Petersen LK, Elfstrom KM, Hammer A, Blaakaer J, Bennetsen MH, Jensen JS, Andersen B. Expanding the upper age limit for cervical cancer screening: a protocol for a nationwide non-randomised intervention study. BMJ Open. 2020 Nov 5;10(11):e039636. doi: 10.1136/bmjopen-2020-039636.'}, {'pmid': '32894896', 'type': 'DERIVED', 'citation': 'Hammer A, Gustafson LW, Christensen PN, Brondum R, Andersen B, Andersen RH, Tranberg M. Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience. Cancer Med. 2020 Nov;9(21):8235-8242. doi: 10.1002/cam4.3399. Epub 2020 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.', 'detailedDescription': 'The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include women who had their last cervical cytology sample or screening invitation recorded 5 years or more ago', 'genderDescription': 'Only women are offered cervical cancer screening', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 to 69 years;\n* Resident in Denmark\n* No record of a cervical cytology or screening invitation in the past 5 years\n* Not registered as ineligible for screening\n\nExclusion Criteria:\n\n* Death\n* Migration to or from Denmark\n* Moving to or from the CDR\n* Residing in the CDR, but having GP in another region\n* A record of hysterectomy'}, 'identificationModule': {'nctId': 'NCT04114968', 'briefTitle': 'Offering Cervical Cancer Screening to Older Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling', 'orgStudyIdInfo': {'id': '2702'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': 'Eligible women residing in the Central Denmark Region will be assigned to intervention group. Women in the intervention group receive an invitation for HPV-based cervical cancer screening by attending either 1) GP-based screening or 2) HPV self-sampling. The self-sampling kit includes the dry Evalyn brush self-sampling device (Rovers Medical Devices B.V, Oss, Netherlands), written and picture-based user instructions on how to collect and mail the self-sample, and a prestamped return envelope addressed to the Department of Pathology, Randers Regional Hospital.', 'interventionNames': ['Other: GP-based screening or HPV self-sampling']}, {'label': 'Control group', 'description': 'Eligible women residing in the other five Danish regions (North, Central, South, Zealand and Capital ) will be assigned to control group. Women in the control group will receive usual care, which for 65-69 year-old women is opportunistic cervical cancer screening at the GP'}], 'interventions': [{'name': 'GP-based screening or HPV self-sampling', 'type': 'OTHER', 'otherNames': ['Opportunistics GP-based screening'], 'description': 'Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'state': 'Randers NØ', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette tranberg Nielsen, phd', 'role': 'CONTACT', 'email': 'mettrani@rm.dk', 'phone': '40113676', 'phoneExt': '+45'}, {'name': 'Berit Andersen, MD, PhD', 'role': 'CONTACT', 'email': 'berand@rm.dk', 'phone': '784 20171', 'phoneExt': '+45'}], 'facility': 'Mette Tranberg Nielsen', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'centralContacts': [{'name': 'Mette Tranberg, Post doc PhD', 'role': 'CONTACT', 'email': 'mettrani@rm.dk', 'phone': '+45 784 20264'}], 'overallOfficials': [{'name': 'Mette T Tranberg, post doc phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Randers Regional Hospital, Central Denmark Region'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}