NCT06336928招募中不适用
A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis
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
- 490
- 试验地点
- 4
- 主要终点
- Assess the sensitivity and specificity of LBx as a screening method for breast cancer
研究概览
简要总结
This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the sensitivity of LBx for the presence of breast cancer in patient cohorts II. Determine the specificity of LBx for the presence of breast cancer in all patient cohorts.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Screening Mammography Cohort: Patients who were referred for screening mammography and had mammography performed within 6 months prior to blood draw or will be undergoing mammography within 6 months after blood draw. Patient must not have personal history of breast cancer, history of breast biopsy or prior abnormal mammography findings are allowed. OR
- •Abnormal Screening Cohort: Patient who has had mammography that revealed abnormal results (BIRADS 3, 4, 5) or abnormal MRI results requiring further testing (additional imaging modality or biopsy). Patients must not have a history of breast cancer, history of breast biopsy, or prior abnormal mammography findings are allowed. The blood draw must occur in the time between the abnormal mammography and start of definitive treatment (surgery or neoadjuvant chemotherapy). Patients who have already undergone surgery/excisional biopsy due to abnormal mammography findings are not eligible. OR
- •New Beast Cancer Cohort: Patients with new biopsy proven diagnosis of breast cancer (invasive breast cancer or DCIS) within 60 days of blood draw who has not started any cancer directed therapy, including surgery, radiation, hormonal therapy or chemotherapy. Any breast cancer type patients at any stage are eligible. OR
- •Remission Breast Cancer Cohort: Patients with personal history of localized breast cancer (stage 1, 2, 3) that has been previously treated with cancer directed therapy, such as surgery, chemotherapy, radiation and/or hormonal therapy who has been in completed remission. Patients must complete their surgery, adjuvant chemotherapy and/or radiation therapy prior to enrollment. The blood draw must occur at least 90 days after completion of the specified treatment modalities. Patients on adjuvant hormonal therapy are eligible to enroll (those who are treated with adjuvant hormonal therapy in combination with CDK4/6 inhibitor must complete CDK4/6 inhibitor therapy prior to enrollment).
排除标准
- •* Patients unable to give informed consent
- •Patients who have received blood transfusion with 14 days prior to study blood draw
- •Patients who had a heart attack, stroke, or pulmonary embolism within 3 months to study blood draw
- •Excisional breast biopsy in the prior 30 days. Needle biopsy of the breast is permitted
研究组 & 干预措施
Observational
Patients undergo blood sample collection and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Assess the sensitivity and specificity of LBx as a screening method for breast cancer
时间窗: Up to 1 year
LBx results using peripheral blood samples will be compared to a pathological diagnosis of breast cancer within 1 year of the liquid biopsy test.
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
不适用
Breast Cancer Liquid Biopsy TrialBreast CancerCancerNCT04962529Anthony Magliocco450
Unknown
不适用
The Study on the Clinical Utility of Liquid Biopsy in Breast CancerBreast CancerNCT02902991Peking Union Medical College200
已完成
不适用
Concordance of Inivata Liquid Biopsy With Standard Tissue BiopsyNon-Small Cell Lung CancerNCT03116633Inivata34
Enrolling By Invitation
不适用
Neurofibromatosis Type 1 Tumor Early Detection StudyMalignant Peripheral Nerve Sheath TumorNeurofibromatosis Type 1Neurofibromatosis 1Plexiform NeurofibromaPlexiform NeurofibromasAtypical NeurofibromaMalignant Peripheral Nerve Sheath TumorsNCT06515860David Miller1,000
进行中（未招募）
不适用
Liquid Biomarker Study in Melanoma and Non-Melanoma Skin CancersMelanoma (Skin Cancer)Basal Cell Carcinoma of SkinBasal Cell Carcinoma of Skin, Site UnspecifiedCutaneous Squamous Cell Carcinoma (CSCC)Merkel Cell Carcinoma of SkinSkin CancerNCT06608511University of Wisconsin, Madison20