CTRI/2023/06/053975
Recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Becton, Dickinson and Company
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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