A blood test for colorectal cancer treatment response monitoring.

Clinical applicability of cell-free circulating tumor DNA testing for treatment response monitoring of patients with metastatic colorectal cancer: the PLCRC-DOLPHIN study

The PLCRC-DOLPHIN study will examine how blood-based cell-free circulating tumor DNA (ctDNA) testing can complement or replace CT-imaging for treatment response monitoring of patients with metastatic colorectal cancer (mCRC). The ctDNA fragmentomics technology of Delfi Diagnostics is suited for the development and application of a broadly applicable, highly sensitive and affordable ctDNA diagnostic test.

In the Netherlands approximately 4.500 patients with mCRC are diagnosed each year. These patients undergo four to six CT scans, i.e. approximately 20.000 CT scans per year in total. For these patients, ctDNA-based diagnostics can improve the clinical outcome and quality of life by improved assessment of treatment response, by reducing futile treatment and by increasingly offering care from the living environment. Living longer with good quality of life will increase the productivity of patients with cancer and result in positive impact on the Dutch economy.

PLCRC-DOLPHIN is a prospective multicenter observational study. In total, 400 mCRC patients who receive systemic treatment will be accrued using the Prospective Dutch ColoRectal Cancer cohort (www.PLCRC.nl) infrastructure. Longitudinally collected blood plasma samples will be analysed for tumor-specific ctDNA fragmentation patterns (Delfi Diagnostics). Clinical, CT-imaging and ctDNA molecular data will be integrated for statistical modeling to identify an optimal treatment response monitoring strategy.

The PLCRC-DOLPHIN study will deliver a ‘Delfi Monitoring Score’ ctDNA test suited for treatment response monitoring that is applied to 3.000 samples from 400 patients with mCRC. The optimal treatment response monitoring strategy will be discussed by an expert panel of medical specialists and patient advocates. This will result in the design of a clinical trial in which the follow-up of patients with mCRC by CT-imaging in hospital setting is partly replaced (or complemented) by decentralised ctDNA testing from the living environment.

Summary

Detection of cell-free circulating tumor DNA in blood samples from patients with metastatic colorectal cancer is indicative of the viable tumor load and offers an alternative for treatment response monitoring by CT-imaging. This could improve personalised treatment decision-making and transfer patient care from the hospital setting to the living environment.

Technology Readiness Level (TRL)

4 - 6

Time period

48 months

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