CTRI/2023/06/053975招募中Unknown
Collection & Processing of Whole Blood Specimens from Breast Cancer Patients for use in the Analytical Studies of the PAXgene Blood ccfDNA Tube US-IVD Project - PAS-20CCF007
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In order to be eligible to participate in this study, an individual must meet the following
- •1.Adult (female or male) at least 18 years of age at the time of signing the informed consent.
- •2.Has confirmed diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer at the time of enrollment. If ER/PR status is not known at the time of enrollment, but the subject otherwise meets the enrollment criteria, they can be enrolled as long as ER/PR test results are obtained within one month of enrollment.
- •3.Must consent to the collection of the required volume of blood (approximately 40mL), collected via a routine venipuncture and provide signed and dated informed consent form.
- •In addition, the subject must meet one of the following three criteria:
- •4. Has breast cancer stage 3 or stage 4 without prior therapy.
- •5. Has metastatic breast cancer without prior therapy for metastatic disease.
- •6. Has metastatic breast cancer with failed therapy before changing therapy.
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •1. Do not meet inclusion criteria.
- •2. Known to be pregnant at the time of enrollment (selfreported).
- •3. Not able or unwilling to comply with study procedures.
- •4. Any other conditions that in the opinion of the Investigator, would
- •exclude the subject from the study.
研究者
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