GUARD TISSUE Registry
This study seeks to quantify measurable improvements in time-to-treatment, molecular testing adequacy, procedural efficiency, cost savings, and long-term patient survival in participating hospitals that adopt the Crow’s Nest™ device.
Summary
Now accepting indications of interest to participate in the GUARD TISSUE Registry Study
The GUARD TISSUE Study (Global Utilization And Registry Database of Tumor bIopsies for Superior Specimen Utilization Efficiency) is a multi-center, retrospective registry designed to evaluate clinical, operational, and economic outcomes associated with the use of the Crow’s Nest™ Biopsy Catchment System in solid tumor biopsy workflows.
The GUARD TISSUE Study will gather real-world data from oncology centers and hospitals that have integrated the Crow’s Nest™ Biopsy Catchment System into their standard-of-care biopsy workflows. This device enables collection of liquid-based biopsy specimens, providing an alternative or complementary substrate to FFPE tissue for molecular testing. The study aims to measure seven specific primary and two secondary outcome metrics related to patient care and operational efficiency, with a focus on reducing delays in precision oncology treatment, lowering insufficient sample rates, and minimizing unnecessary repeat biopsies. Over the study period, participating institutions will contribute anonymized patient-level data, subject to IRB review, enabling a comprehensive evaluation of the system's effectiveness at improving clinical and financial outcomes as measured by seven quantitative primary endpoints.
This study is a registry study collecting data both retrospectively from solid tumor cancer patients who have already undergone a core needle biopsy procedure, and prospectively from consecutively enrolled solid tumor cancer patients for core needle biopsies. The study is a chart review study.
Ongoing eligible recipients will undergo core needle biopsy according to standard practices at each participating institution. The biopsies of a subset of those patients (the number determined by each participating institution) will be treated with the Crow’s Nest Biopsy Catchment System, as an alternative to the standard Telfa-pad-transfer-to-formalin-cup approach.
Background
- (Secondary endpoint) Data Concordance Between Liquid and Solid Specimens: Will be measured once following receipt of the molecular testing lab reports for the two respective specimens from each biopsy treated with a Crow’s Nest Device. Those patients whose biopsies are treated solely conventionally, without the use of the Crow’s Nest will not be measured for concordance.
- (Secondary endpoint) Confirmation of no change in FFPE Tissue Specimen Integrity: Will be measured via visual microscopic examination by a pathologist designated by the institution once following each biopsy procedure in which a Crow’s Nest Biopsy Catchment System was used.
This study will be conducted at an estimated 25 institutions globally and will include up to 3,000 core needle biopsy procedures.
Of the seven primary and two secondary endpoints:
- Time-to-Treat (TTT): Will be measured once for each biopsied patient in the study.
- QNS (Quantity Not Sufficient) Rate: Will be computed at 6 months following the initial enrollment at each center, and every 6 months thereafter until the final QNS rate is computed three years (36 months) after each institution commenced enrollment.
- Second Biopsy Rate: Will be computed at 6 months following the initial enrollment at each center, and every 6 months thereafter until the final QNS rate is computed three years (36 months) after each institution commenced enrollment.
- Unreimbursed Biopsy Procedure Expense: Will be measured via a retrospective chart review at 12 months following the initial enrollment at each center, and every 12 months thereafter until the final expense is measured three years (36 months) after each institution commenced enrollment.
- Lab Reagent Cost Savings: Will be measured via a retrospective chart review at 12 months following the initial enrollment at each center, and every 12 months thereafter until the final reagent cost savings is measured three years (36 months) after each institution commenced enrollment.
- Clinical Lab Labor Cost Savings: Will be measured via a retrospective chart review at 12 months following the initial enrollment at each center, and every 12 months thereafter until the final labor cost savings is measured three years (36 months) after each institution commenced enrollment.
- Survival Rate: May be measured at three (3) years following the initial biopsy.
Inclusion Criteria:
Exclusion Criteria:
- Hospitals or oncology centers performing core needle biopsies on solid tumor patients.
- Adoption and routine use of the Crow’s Nest™ Biopsy Catchment System.
- Willingness to share de-identified clinical, operational, and financial outcomes data.
Exclusion Criteria:
- Facilities not performing core needle biopsies.
Participation Criteria
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