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The Caris registry: Building a biomarker-focused database to advance patient care

Authors:

Sheri Sanders, Wendy Schroeder, Alan Wright, Jeff Field

Background:

The medical community is continually searching for the best way to treat cancer. The value and utility of biomarkers in guiding treatment decisions is widely accepted but remains a challenge for the bedside clinician and requires ongoing validation and correlation to clinical outcomes. Caris Life Sciences has a dedicated team of scientists who study volumes of scientific literature, synthesize biomarker research and by way of an evidence-based electronic rules engine, translates the application of the literature to biomarker analysis of tumor tissue (The Target Now Report) in support of biomarker-drug association evidence useful in clinical decision-making. Subsequently, Caris initiated the Caris Registry to capture clinical disease, treatment and outcome data from patients who have a Target Now Report.

Methods:

The Caris Registry is a web-based data entry platform based on an IRB approved protocol. The eligible subject for the Registry will have a qualified Target Now Report. All clinical data elements are defined and supported by the NCI caBIG standardized data dictionary. Disease history/status, treatments and outcomes are captured at enrollment with Day 1 defined as the date of the Target Now Report and every 9 months for 5 years or death whichever is first.

Results:

As of January 19, 2012, there are 68 participating centers across the country and 43 centers pending IRB submission. There are 852 Target Now cases enrolled with the following cancer lineage distribution: Breast 209, Ovary 169, Lung 117, Colon 79, Endometrium 33, and other 245. There are 323 completed follow up reports and 175 completed end of study reports capturing vital status and cancer related deaths.

Conclusions:

Caris has successfully launched a scientifically valid and regulatory compliant Registry and database intended to become a robust library of tumor biomarker results linked to clinical outcomes data. As the library grows, data mining could provide vital information access to researchers, pharmaceutical firms, government, academia and insurers for use in drug development, molecular and biomarker research, economic impact assessments, healthcare policy discussion and most importantly directing personalized cancer treatment.

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