AI Article Synopsis
- Early-phase cancer clinical trials are increasingly available for advanced cancer patients who have few treatment options left, often requiring research tissue biopsies.
- An audit over two years showed that ultrasound-guided research biopsies were safe, yielded sufficient tumor samples, and revealed actionable mutations in 30% of cases tested with next-generation sequencing.
- Despite these benefits, the direct advantages of the research biopsies were limited to a minority of patients, highlighting the need for clear and informed consent in these procedures.
Article Abstract
Early-phase cancer clinical trials are becoming increasingly accessible for patients with advanced cancer who have exhausted standard treatment options and later phase trial options. Many of these trials mandate research tissue biopsies. Research biopsies have been perceived as ethically fraught due to the perception of potential coercion of vulnerable human subjects. We performed an audit of two years of practice to assess the safety of ultrasound (US)-guided research biopsies, and to look at the yield of a simultaneous tumour next-generation sequencing (NGS) and immunohistochemistry (IHC) molecular characterisation programme. We show that in our institution, US-guided research biopsies were safe, produced adequate tumour content and in a selected subset who underwent in-house NGS sequencing, showed a high rate of actionable mutations with 30% having a Tier 1 variant. Nevertheless, these research biopsies may only provide direct benefit for a minority of patients and we conclude with a reflection on the importance of obtaining truly informed consent.
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| http://dx.doi.org/10.1016/j.ctarc.2021.100309 | DOI Listing |
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