Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure
概览
- 阶段
- 不适用
- 干预措施
- Harvard Health Professionals survey
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- differences in DNA somatic mutational profile
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This study is designed to find out how engaging in regular exercise (or not) alters the biology of breast tumors as well as the normal tissue (if available) surrounding the tumor. The investigators hope that findings from this initial study will guide the design of future studies to examine how changes in exercise alter breast tumor biology.
研究者
入排标准
入选标准
- •Cohort 1: Breast Cancer Patients
- •Ages 21-80 years
- •Histologically confirmed ER receptor positive (\>1% staining), HER2 negative (FISH ratio \<1.8), untreated operable breast cancer
- •Stage I to II disease
- •Scheduled for surgical resection by any type of mastectomy or lumpectomy at MSK
- •Tumor size ≥1cm by preoperative imaging or physical examination
- •Categorization into self-reported exercise history exposure classifications as follows: (1) exercising: ≥120 minutes of vigorous-intensity exercise/wk for the past 12 months, and (2) sedentary (non-exercising): ≤ 30 minutes of moderate-intensity exercise/week for the past months using the Harvard Health Professionals survey.(34)
- •Ability to read and understand English
- •Willing and able to comply with requirements of the protocol
- •Cohort 2: High-Risk Patients
排除标准
- •Received any form of neoadjuvant treatment
- •Presence of any other concurrent, actively treated malignancy
- •Presence of metastatic disease
- •If performing a CPET, any of the following contraindications:
- •Acute myocardial infarction within 3-5 days of any planned study procedures;
- •Unstable angina
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
研究组 & 干预措施
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
干预措施: Harvard Health Professionals survey
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
干预措施: Blood draw
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
干预措施: CPET Procedures
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
干预措施: stool sample
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
干预措施: Research Tissue sampling
Regular exercisers who are at high risk of developing breast cancer
≥120 minutes of vigorous-intensity aerobic exercise;
干预措施: Harvard Health Professionals survey
Regular exercisers who are at high risk of developing breast cancer
≥120 minutes of vigorous-intensity aerobic exercise;
干预措施: Research Tissue sampling
结局指标
主要结局
differences in DNA somatic mutational profile
时间窗: 2 years
Eight-μm-thick representative sections of the fresh-frozen sample will be microdissected with a needle under a stereomicroscope (Olympus SZ61), to ensure \>70% of tumor cell content as previously described.(36) Matched germline DNA will be microdissected from adjacent normal breast tissue (if available) for each case; to avoid the possibility of morphologically appearing non-neoplastic cells harboring somatic mutations; we will prioritize the microdissection of stromal cells and avoid normal breast ducts and lobules.
differences in RNA sequencing
时间窗: 2 years
The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq