A recent study published in The Lancet Oncology sought to assess the effectiveness of a methylation-based multicancer early detection (MCED) diagnostic test in symptomatic patients referred from primary care as a means to stratify cancer risk by analyzing circulating tumor DNA.

Conducted at various National Health Service (NHS) hospital sites in England and Wales, this multicenter prospective observational study included participants aged 18 and above who were referred with non-specific symptoms or symptoms possibly related to gynecological, lung, or upper/lower gastrointestinal cancers. Participants provided blood samples during their urgent investigations. Excluded were those with a history of invasive or haematological malignancy diagnosed within the prior 3 years, individuals taking cytotoxic or demethylating agents that could affect the test, or those who had already participated in another study involving a GRAIL MCED test.

Patient follow-up continued until diagnostic resolution or up to 9 months. Cell-free DNA was extracted and the MCED test was administered, with the clinical outcomes kept blind to those performing the test. The primary outcomes, encompassing overall positive and negative predictive values, sensitivity, and specificity, were determined by comparing MCED predictions with the diagnoses obtained through standard care. These outcomes were assessed for participants with a valid MCED test result and diagnostic resolution.

It’s worth noting that the SYMPLIFY study is registered with ISRCTN (ISRCTN10226380) and has concluded follow-up at all participating sites.

Read more here.

References

  1. Nicholson, B. D., Oke, J., Virdee, P. S., Harris, D., O’Doherty, C., Park, J., Hamady, Z., Sehgal, V., Millar, A., Medley, L., Tonner, S., Vargova, M., Engonidou, L., Riahi, K., Liu, Y., Hiom, S., Kumar, H., Nandani, H., Kurtzman, K. N., . . . Middleton, M. R. (2023). Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study. Lancet Oncology, 24(7), 733–743. https://doi.org/10.1016/s1470-2045(23)00277-2

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