NCT03729115招募中不适用
Chicago Alternative Prevention Study for BreAst CAncer inHigh Risk Women - CAPSBRACA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
研究概览
简要总结
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.
- •Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.
- •WISDOM study participant recommended to have MRI every 6 months. OR
- •Patients with history of chest wall radiation received before age
- •Must be at least 25 years old.
- •Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
- •Be able to give informed consent.
- •Patients with prior history of breast or ovarian or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.
- •Willing to travel to the University of Chicago Medicine
排除标准
- •Undergoing active cancer treatment at the time of enrollment.
- •Current pregnancy.
- •Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
- •Breast surgery within two weeks of study entry.
- •Women with history of bilateral mastectomy are not eligible
- •History of kidney disease or abnormal kidney function.
- •History of dye allergy unless it can be mediated with antihistamines and/or steroids
- •Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
- •Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.
- •Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.
研究组 & 干预措施
Screening Arm
Other
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
时间窗: 5 years
We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI.
次要结局
未报告次要终点
研究者
研究点 (3)
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