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PAXgene Blood ccfDNA Tube Clinical Specimen Collection

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053975
Enrollment
200
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: PAXgene Blood ccfDNA Tube: Three PAXgene Blood ccfDNA tubes, 10 mL per tube one visit only Control Intervention1: K2EDTA tube: one K2EDTA 10 mL tube

Sponsors

Becton, Dickinson and Company
Lead Sponsor

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 (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

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

MeasureTime frame
The objective of this study is to collect & process blood samples for further analysis by the Sponsor under a different protocol.Timepoint: There is only one visit.—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Sneha Asai

LINQ LAB

Sneha.asai@linqlabs.com02026113878

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026