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Matching cancer patients to early phase clinical trials

Blood-based genomic profiling can identify patients with cancer who might benefit from enrolment in an early clinical trial, according to research published in Nature Medicine this week.

The data from the Tumour chARacterisation to Guide Experimental Targeted therapy (TARGET) study support the application of next generation sequencing of circulating tumour DNA in the early phase trial setting, where broad genomic profiling of contemporaneous tumour material can enhance patient stratification to novel therapies.

TARGET is a molecular profiling programme with the primary aim of matching patients with a broad range of advanced cancers to early phase clinical trials based on analysis of both somatic mutations and copy number alterations across a 641 cancer-associated gene panel in a single ctDNA assay.

When applying a 2.5% variant allele frequency threshold, actionable mutations were identified in 41 of the first 100 patients referred to the Experimental Cancer Medicine Team at the Christie NHS Foundation Trust for consideration for early phase trials. Eleven of these patients were subsequently enrolled onto an available and molecularly matched clinical trial.

The data support the application of ctDNA in the early phase trial setting, where broad genomic profiling of contemporaneous tumour material enhances patient stratification to novel therapies and provides a practical template for bringing routinely applied blood-based analyses to the clinic, the authors say.

They encourage routine implementation of ctDNA testing as an adjunct to tumour analysis, where tumour analysis would be applied only in cases with low tumour burden or ctDNA yield, thereby reducing the need for invasive procedures.


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