PAXgene Blood ccfDNA Tube Validation Study
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/06/053729
- Lead Sponsor
- Becton, Dickinson and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
In order to be eligible to participate in this study, an individual must meet the following
criteria:
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 (approximate 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method