Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer
NCT ID: NCT03165006
Last Updated: 2017-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1086 participants
OBSERVATIONAL
2013-01-01
2015-12-31
Brief Summary
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This study is part of a broader project (CAMISS study), which also includes one prospective cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).
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Detailed Description
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The 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)).
Expected 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.
This 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).
The 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Screened women with breast cancer
Mode of detection: Cancer detected at screening
Cancers detected as a result of screening mammograms.
Mode of detection: Interval cancer
Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)
Interventions
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Mode of detection: Cancer detected at screening
Cancers detected as a result of screening mammograms.
Mode of detection: Interval cancer
Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
69 Years
FEMALE
No
Sponsors
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Fondo de Investigacion Sanitaria
OTHER
European Regional Development Fund
OTHER
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
OTHER
Parc de Salut Mar
OTHER
Responsible Party
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Maria Sala
MD, PhD
References
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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.
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.
Related Links
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Related Info
Other Identifiers
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CAMISS study
Identifier Type: -
Identifier Source: org_study_id
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