Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07371702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERsonalized Mammographic Screening in Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2033-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density', 'timeFrame': 'Women will be invited to the extra examination with DBT within 6 months after index screening mammography.', 'description': 'Women with extremely dense breasts will be offered an extra examination with DBT within 6 months after index screening mammography. The investigators will assess the attendance rate to this extra examination.'}, {'measure': 'Attendance rate to an additional screening mammography for women with false positive screening result', 'timeFrame': 'Women will be invited to the additional screening mammography within 12 months after index screening mammography.', 'description': 'Women with false positive screening result will be offered an additional screening mammography within 12 months after index screening mammography. The investigators will assess the attendance rate to this additional examination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer Screening', 'personalized screening', 'breast cancer screening; personalized screening'], 'conditions': ['Breast Cancer', 'Mammographic Breast Density', 'Risk Stratification']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess attendance among women invited to additional breast imaging because they were identified as having an increased risk of breast cancer at screening. High-risk women were defined in two studies: Study A; women with high mammographic density, representing approximately 3-5% of screened women, and Study B; women with a false-positive screening result. Women in Study A will be offered an additional screening examination with digital breast tomosynthesis immediately within 6 months after the screening examination. Women in Study B will be offered an additional standard digital mammography examination one year after their initial screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study A will take place at the University Hospital of Akershus, while Study B will take place in Drammen, Vestre Viken Hospital and Oslo University Hospital', 'genderDescription': 'Only women are invited to mammographic screening', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invited to screening\n* extremely dense breast (Study A) or a false positive screening result (Study B)\n\nExclusion Criteria:\n\n* Opted out or not signed written consent related to the study\n* Women who have opted out from giving us permission to use screening data for quality assurance and research'}, 'identificationModule': {'nctId': 'NCT07371702', 'acronym': 'PERMS', 'briefTitle': 'PERsonalized Mammographic Screening in Norway', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': 'PERsonalized Mammographic Screening in Norway; Additional Examination for Women With Increased Risk of Breast Cancer', 'orgStudyIdInfo': {'id': '585149'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women attending mammographic screening at three sites in BreastScreen Norway', 'description': 'Those 3-5% with the highest mammographic density in Study A and those with a false positive screening result in Study B will be offered additional imaging with digital breast tomosynthesis within 6 months after the screening examination (A) and an additional standard screening examination after one year (B)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Solveig Hofvind, PhD, professor', 'role': 'CONTACT', 'email': 'sshh@fhi.no', 'phone': '+47 406 45 346'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared outside the project group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Norwegian Cancer Society', 'class': 'OTHER'}, {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}