Detection by Circulating RNA With Optimized Machine Learning Technology for Breast Cancer: DROPLET-BC Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Sensitivity of the Droplet-BC screening test for detecting breast cancer
研究概览
简要总结
This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. This study also investigates if this test can classify the subgroup of breast cancer patients with a variety of conditions. Information from this study may provide a new method of breast cancer screening/diagnosis
详细描述
PRIMARY OBJECTIVE:
I. To determine the sensitivity and specificity of the Droplet-BC screening test for distinguishing breast cancer (BC) patients from non-cancer volunteers, using reference data confirmed at sites.
SECONDARY OBJECTIVES:
I. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of early-stage BC.
II. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for classifying patients into non-cancer volunteer (Breast Imaging-Reporting and Data System [BI-RADS] Categories 1 and 2) and BC patient subgroups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BREAST CANCER PATIENTS: Newly diagnosed with breast cancer
- •BREAST CANCER PATIENTS: Not received cancer treatment for newly diagnosed with breast cancer
- •BREAST CANCER PATIENTS: Able to comprehend, sign, and date the written informed consent document to participate in the study
- •BREAST CANCER PATIENTS: Able and willing to provide a one-time blood sample
- •BREAST CANCER PATIENTS: Age >= 18 years old
- •NON-CANCER VOLUNTEERS: Have undergone a screening mammogram
- •NON-CANCER VOLUNTEERS: Not currently taking any drugs for cancer treatment or any cancer prevention medication
- •NON-CANCER VOLUNTEERS: Able to comprehend, sign, and date the written informed consent document to participate in this study
- •NON-CANCER VOLUNTEERS: Able and willing to provide blood samples according to provided written instructions
- •NON-CANCER VOLUNTEERS: Seen by a provider (physician or advanced practice nurse [APN]) in the Cancer Prevention clinic at MD Anderson Cancer Center or other participating sites
- •NON-CANCER VOLUNTEERS: Age >= 18 years old
排除标准
- •BREAST CANCER PATIENTS: Known current pregnancy
- •BREAST CANCER PATIENTS: History of breast cancer treatment in the past
- •BREAST CANCER PATIENTS: Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
- •BREAST CANCER PATIENTS: Any condition that, in the opinion of the investigator, should preclude participation in the study
- •NON-CANCER VOLUNTEERS: Known current pregnancy
- •NON-CANCER VOLUNTEERS: History of breast cancer (breast ductal carcinoma in situ [DCIS] and invasive)
- •NON-CANCER VOLUNTEERS: History of any cancer except non-melanoma skin cancer and cervical dysplasia
- •NON-CANCER VOLUNTEERS: Participation in any interventional clinical study within the previous 30 days in which experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
- •NON-CANCER VOLUNTEERS: Any condition that in the opinion of the investigator, should preclude participation in the study
结局指标
主要结局
Sensitivity of the Droplet-BC screening test for detecting breast cancer
时间窗: Up to study completion (estimated 18 months)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for detecting breast cancer
时间窗: Up to study completion (estimated 18 months)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
次要结局
- Specificity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (BI-RADS categories 1 and 2) and BC patient subgroups(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)(Up to study completion (estimated 18 months))
- Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)(Up to study completion (estimated 18 months))
- Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC)(Up to study completion (estimated 18 months))
- Specificity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results(Up to study completion (estimated 18 months))
- Sensitivity of Droplet-BC test compared with magnetic resonance imaging (MRI) for detecting BC by extracting a subgroup of BC patients that have MRI results(Up to study completion (estimated 18 months))
- Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (Breast Imaging Reporting and Data System [BI-RADS] categories 1 and 2) and BC patient subgroups(Up to study completion (estimated 18 months))
- Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results(Up to study completion (estimated 18 months))