{ "FullStudy":{ "Rank":218208, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511328", "OrgStudyIdInfo":{ "OrgStudyId":"SLL-KI-HPV" }, "Organization":{ "OrgFullName":"Karolinska Institutet", "OrgClass":"OTHER" }, "BriefTitle":"Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm", "OfficialTitle":"Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm" }, "StatusModule":{ "StatusVerifiedDate":"March 2017", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2017", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2017", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"December 20, 2011", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 1, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 3, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Joakim Dillner", "ResponsiblePartyInvestigatorTitle":"Professor of infectious disease epidemiology", "ResponsiblePartyInvestigatorAffiliation":"Karolinska Institutet" }, "LeadSponsor":{ "LeadSponsorName":"Karolinska Institutet", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Stockholm County Council, Sweden", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.", "DetailedDescription":"Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology.\n\nCervical cancer screening at age 60:\n\nCytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today.\n\nCervical cancer screening at age 30-40:\n\nHPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "High-grade Cervical Intraepithelial Neoplasia" ] }, "KeywordList":{ "Keyword":[ "HPV testing", "Primary screening", "Cervical Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Screening", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"270000", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"HPV testing", "ArmGroupType":"Experimental", "ArmGroupDescription":"Women randomised to this arm get primary HPV testing", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: HPV testing" ] } },{ "ArmGroupLabel":"cytology", "ArmGroupType":"No Intervention", "ArmGroupDescription":"women included follow the standard procedure with primary cytology" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"HPV testing", "InterventionDescription":"Testing for Human Papilloma Virus", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "HPV testing" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"number of CIN 2+ cases for the two different diagnostic procedures", "PrimaryOutcomeDescription":"The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology", "PrimaryOutcomeTimeFrame":"first evaluation, the 1 of january 2013" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"calculation of cost for the two different diagnostic procedures", "SecondaryOutcomeDescription":"The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology", "SecondaryOutcomeTimeFrame":"first evaluation, 1 of January 2013" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"30 Years", "MaximumAge":"64 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Joakim Dillner, MD, PhD", "OverallOfficialAffiliation":"Karolinska Institutet", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Karolinska University Hospital", "LocationCity":"Stockholm", "LocationZip":"141 86", "LocationCountry":"Sweden" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"19796748", "ReferenceType":"background", "ReferenceCitation":"Arbyn M, Ronco G, Meijer CJ, Naucler P. Trials comparing cytology with human papillomavirus screening. Lancet Oncol. 2009 Oct;10(10):935-6. doi: 10.1016/S1470-2045(09)70296-7." },{ "ReferencePMID":"19141778", "ReferenceType":"background", "ReferenceCitation":"Naucler P, Ryd W, Törnberg S, Strand A, Wadell G, Elfgren K, Rådberg T, Strander B, Forslund O, Hansson BG, Hagmar B, Johansson B, Rylander E, Dillner J. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J Natl Cancer Inst. 2009 Jan 21;101(2):88-99. doi: 10.1093/jnci/djn444. Epub 2009 Jan 13." },{ "ReferencePMID":"28566363", "ReferenceType":"derived", "ReferenceCitation":"Lamin H, Eklund C, Elfström KM, Carlsten-Thor A, Hortlund M, Elfgren K, Törnberg S, Dillner J. Randomised healthcare policy evaluation of organised primary human papillomavirus screening of women aged 56-60. BMJ Open. 2017 May 30;7(5):e014788. doi: 10.1136/bmjopen-2016-014788." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002583", "ConditionMeshTerm":"Uterine Cervical Neoplasms" },{ "ConditionMeshId":"D000018290", "ConditionMeshTerm":"Cervical Intraepithelial Neoplasia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014594", "ConditionAncestorTerm":"Uterine Neoplasms" },{ "ConditionAncestorId":"D000005833", "ConditionAncestorTerm":"Genital Neoplasms, Female" },{ "ConditionAncestorId":"D000014565", "ConditionAncestorTerm":"Urogenital Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000002577", "ConditionAncestorTerm":"Uterine Cervical Diseases" },{ "ConditionAncestorId":"D000014591", "ConditionAncestorTerm":"Uterine Diseases" },{ "ConditionAncestorId":"D000005831", "ConditionAncestorTerm":"Genital Diseases, Female" },{ "ConditionAncestorId":"D000002278", "ConditionAncestorTerm":"Carcinoma in Situ" },{ "ConditionAncestorId":"D000002277", "ConditionAncestorTerm":"Carcinoma" },{ "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M4413", "ConditionBrowseLeafName":"Uterine Cervical Neoplasms", "ConditionBrowseLeafAsFound":"Cervical Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M19018", "ConditionBrowseLeafName":"Cervical Intraepithelial Neoplasia", "ConditionBrowseLeafAsFound":"Cervical Intraepithelial Neoplasia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15925", "ConditionBrowseLeafName":"Uterine Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7528", "ConditionBrowseLeafName":"Genital Neoplasms, Female", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15898", "ConditionBrowseLeafName":"Urogenital Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4408", "ConditionBrowseLeafName":"Uterine Cervical Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15922", "ConditionBrowseLeafName":"Uterine Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7526", "ConditionBrowseLeafName":"Genital Diseases, Female", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4117", "ConditionBrowseLeafName":"Carcinoma in Situ", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T1080", "ConditionBrowseLeafName":"Cervical Intraepithelial Neoplasia", "ConditionBrowseLeafAsFound":"Cervical Intraepithelial Neoplasia", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }