Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: PAXgene
Blood ccfDNA
Tube: Two PAXgene
Blood ccfDNA tubes, 10 mL
per tube
Control Intervention1: K2EDTA tube: one K2EDTA 10 mL tube
Sponsors
Becton, Dickinson and Company
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical equivalence of the PAXgene Blood ccfDNA Tube in comparison with the BD Vacutainer K2EDTA tube for the detection of PIK3CA mutationsTimepoint: OPA, PPA & NPA for detection of PIK3CA mutations with PAXgene Blood ccfDNA Tube as compared to BD Vacutainer K2EDTA | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the stability of target ccfDNA analytes (mutations) tested by the therascreen® PIK3CA RGQ PCR Kit using clinical blood specimen stored in the PAXgene Blood ccfDNA Tubes.Timepoint: OPA, PPA & NPA for detection of PIK3CA mutations with PAXgene Blood ccfDNA Tube, from specimen processed for plasma after storage for 7 days at room temperature, (15-25ºC) as compared to specimen processed for plasma within 4 hours of collection | — |
Countries
India
Contacts
Public ContactDr Sneha Asai
Linq Therapeutics Pvt. Ltd.
Outcome results
None listed