CAMISS Retrospective Cohort - Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,086
- 主要终点
- Mortality
研究概览
简要总结
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.
This study is part of a broader project (CAMISS study), which also includes one prospective cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).
详细描述
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.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 50 to 69 years with invasive or in situ breast cancer.
排除标准
- •Women diagnosed with lobular carcinoma in situ.
结局指标
主要结局
Mortality
时间窗: From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years
Death from any cause
次要结局
- Recurrences and second breast neoplasms(From date of cancer diagnosis until the date of the first recurrence or second breast neoplasm, whichever came first, assessed up to 14 years)
- Treatment-related complications(From the date of surgery until the end of follow-up, assessed up to 14 years.)
- Readmissions to hospital for reasons related to breast cancer(From the date of surgery until the end of follow-up, assessed up to 14 years.)
研究者
Maria Sala
MD, PhD
Parc de Salut Mar