Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
试验速览
- 阶段
- 不适用
- 入组人数
- 1,341,172
- 试验地点
- 7
- 主要终点
- Patient Reported Outcomes (Aim 1)
研究概览
简要总结
This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.
详细描述
Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI) by extent of breast density.
Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast imaging specialist vs. general radiologist).
Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive breast cancer.
Covid-19 Enhancement Aim and Hypotheses:
Develop patient-focused messaging content through focus groups that radiology facilities can use when scheduling appointments to inform women of the safety to schedule or postpone breast screening or diagnostic services.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Reported Outcomes (Aim 1)
时间窗: Measured within one year post-screening
Patient surveys targeted to determining outcomes of interest to patients
Screening Harms: Recall rate (Aim 1)
时间窗: Within one year after screen
Number of positive screens divided by total number of screens
Screening Harms: Other consequences (Aim 1)
时间窗: Within one year after screen
Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
Screening Failures: Interval or advanced breast cancer rate (Aim 1)
时间窗: Within one year after screen
Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
时间窗: Within one year after screen
Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
Screening Harms: False-positive (FP) recall rate (Aim 1)
时间窗: Within one year after screen
Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
Screening Harms: FP biopsy recommendation rate (Aim 1)
时间窗: Within one year after screen
Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
Rates of additional breast cancers detected (Aim 2)
时间窗: 6 months after initial diagnosis
Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
3-year rate of 2nd breast cancer events (Aim 2)
时间窗: 3 years after initial diagnosis
Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers
Patient Reported Outcomes (Aim 2)
时间窗: Measured 6-18 months post-diagnosis
Patient surveys targeted to determining outcomes of interest to patients
次要结局
- Negative predictive value of work-up without MRI (Aim 2)(6 months after initial diagnosis)
- Performance Measures: Positive predictive value (Aim 1)(Within one year after screen)
- Performance Measures: Specificity (Aim 1)(Within one year after screen)
- Definitive surgery type (Aim 2)(6 months after initial diagnosis)
- Surgical biopsy rate (Aim 2)(6 months after initial diagnosis)
- Benign biopsy rate (Aim 2)(6 months after initial diagnosis)
- Performance Measures: Sensitivity (Aim 1)(Within one year after screen)
- Core biopsy rates (Aim 2)(6 months after initial diagnosis)
- Negative predictive value of work-up with MRI (Aim 2)(6 months after initial diagnosis)