Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT03165006
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2017-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1086}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years', 'description': 'Death from any cause'}], 'secondaryOutcomes': [{'measure': 'Recurrences and second breast neoplasms', 'timeFrame': 'From date of cancer diagnosis until the date of the first recurrence or second breast neoplasm, whichever came first, assessed up to 14 years'}, {'measure': 'Treatment-related complications', 'timeFrame': 'From the date of surgery until the end of follow-up, assessed up to 14 years.'}, {'measure': 'Readmissions to hospital for reasons related to breast cancer', 'timeFrame': 'From the date of surgery until the end of follow-up, assessed up to 14 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer, screening, survival'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27632982', 'type': 'RESULT', 'citation': 'Romero A, Tora-Rocamora I, Bare M, Barata T, Domingo L, Ferrer J, Tora N, Comas M, Merenciano C, Macia F, Castells X, Sala M; CAMISS Study Group. Prevalence of persistent pain after breast cancer treatment by detection mode among participants in population-based screening programs. BMC Cancer. 2016 Sep 15;16(1):735. doi: 10.1186/s12885-016-2768-1.'}, {'pmid': '31805926', 'type': 'DERIVED', 'citation': 'Miret C, Domingo L, Louro J, Barata T, Bare M, Ferrer J, Carmona-Garcia MC, Castells X, Sala M. Factors associated with readmissions in women participating in screening programs and treated for breast cancer: a retrospective cohort study. BMC Health Serv Res. 2019 Dec 5;19(1):940. doi: 10.1186/s12913-019-4789-3.'}], 'seeAlsoLinks': [{'url': 'http://www.camiss.info', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter retrospective cohort of women participating in breast cancer screening programs in Spain between 2000 and 2009, with a cancer diagnosed during the screening or between the screening interval (interval cancer), specifically true interval cancers and false negatives. The investigators obtained woman-related information (including breast density), tumor-related information (including tumor phenotype), and follow-up information (including relapses, second neoplasms and vital status at the end of follow up (June 2014)). The objective is to evaluate the survival and disease-free period of women participating in screening programs for breast cancer with a cancer diagnosed during the screening or an interval cancer, specifically true interval cancers and false negatives.\n\nThis study is part of a broader project (CAMISS study), which also includes one prospective cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).', 'detailedDescription': 'The general objective for this study is to evaluate the survival and disease-free period of women participating in screening programs for breast cancer with a cancer diagnosed during the screening or an interval cancer, specifically true interval cancers and false negatives.\n\nThe cohort has information of women participating in breast cancer screening programs in Spain between 2000 and 2009, with a breast cancer diagnosed during the screening or between the screening interval (interval cancer), specifically true interval cancers and false negatives. The investigators obtained woman-related information (including breast density), tumor-related information (including tumor phenotype), and follow-up information (including relapses, second neoplasms and vital status at the end of follow up (June 2014)).\n\nExpected results: Nowadays there are no results of cohort analysis of the diagnostic process of care that integrates all those different aspects. This study will complement the evaluation of population screening, specifically the interval cancer and the impact on survival and disease-free period taking into account relevant variables like breast density, tumor phenotype, clinical complications, readmissions, and the surgical approach.\n\nThis study is part of a broader project (CAMISS study) coordinated by the Evaluation of Health Services of Epidemiology and Public Health Group, which consists of two cohorts of women diagnosed with breast cancer: a prospective cohort (n=2,040 incident cases of breast cancer diagnosed in 18 hospitals of 5 Spanish regions) (Identifier in ClinicalTrials.gov: NCT02439554) and a retrospective cohort of screened women diagnosed with breast cancer between 2000 and 2009 in two Spanish regions (n=1,086).\n\nThe general objective of the CAMISS study is to evaluate different aspects of health care received by patients with breast cancer like the diagnostic process, treatment, complications, survival, costs and quality of life to provide information to improve the effectiveness and cost-effectiveness of interventions, reduce variability, have better predictive rules and increase the quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women screened for breast cancer and diagnosed for breast cancer in the screening program (screen-detected cancer) or within the interval between 2 screening rounds (interval cancer)', 'genderDescription': 'Women participating at screening', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 50 to 69 years with invasive or in situ breast cancer.\n\nExclusion Criteria:\n\n* Women diagnosed with lobular carcinoma in situ.'}, 'identificationModule': {'nctId': 'NCT03165006', 'briefTitle': 'Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'CAMISS Retrospective Cohort - Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer', 'orgStudyIdInfo': {'id': 'CAMISS study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screened women with breast cancer', 'interventionNames': ['Procedure: Mode of detection: Cancer detected at screening', 'Procedure: Mode of detection: Interval cancer']}], 'interventions': [{'name': 'Mode of detection: Cancer detected at screening', 'type': 'PROCEDURE', 'description': 'Cancers detected as a result of screening mammograms.', 'armGroupLabels': ['Screened women with breast cancer']}, {'name': 'Mode of detection: Interval cancer', 'type': 'PROCEDURE', 'description': 'Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)', 'armGroupLabels': ['Screened women with breast cancer']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondo de Investigacion Sanitaria', 'class': 'OTHER'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}, {'name': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Maria Sala', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}