Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 4
- 主要终点
- Difference in rate of change between the high risk groups and the respective controls
研究概览
简要总结
This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).
详细描述
Preliminary data show Optical Breast Spectroscopy (OBS)has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. In the present study, we want to determine whether OBS has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occurring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). The overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be initiated or when more drastic primary prevention measures are recommended.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BrCa carriers (cases)
- •Attending one of the three participating high-risk screening centres
- •Confirmed BrCa1 or BrCa2 mutation status through genetic testing
- •High-Risk (cases)
- •Attending one of the three participating high-risk screening centres
- •Confirmed negative BrCa1/2 status through genetic testing
- •BrCa non-carriers (controls)
- •Attain a GAIL model score of <1.1 and have <10% risk of carrying the BRCa mutation Determined by the Penn II model)
- •Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
- •Preference will be given to sisters or first degree cousins of BrCa carriers
排除标准
- •Cases and Controls
- •Prior diagnosis or Breast or Ovarian Cancer
- •Bilateral biopsy or fine needle aspiration within 1 year of study start
- •Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
- •Previous or current chemotherapy or prevention therapy (Tamoxifen)
- •Less than 3 years post pregnancy at study start
- •inability to provide informed consent due to language or cognitive difficulties
- •*For controls only
- •Family history of breast cancer where family member had an early diagnosis (before age 45 years)
- •Family history or ovarian cancer
结局指标
主要结局
Difference in rate of change between the high risk groups and the respective controls
时间窗: over the 4 year duration of the study
the primary optical measurements are utilized to determine principal component scores in the analysis which in turn will be used as time dependent variable in a linear regression analysis to determine the rate of change.
次要结局
未报告次要终点