Cancer recognition and assessment through non-invasive evaluation (CRANE): A prospective clinical validation study of a multi-biomarker class multi-cancer early detection (MCED) test in Japan.

Abstract

TPS10629 Background: Japan has established screening programs for gastric, colorectal, lung, cervical, and breast cancers. Blood-based multi-cancer early detection (MCED) tests utilize the measurement of shared tumor-derived biomarkers (ctDNA, proteins) and machine learning to simultaneously detect several cancer types. By complementing current cancer screening, MCED testing has the potential to detect a wide range of cancers at earlier stages and expand existing screening efforts. CRANE is a prospectively collected, case-control study of Exact Sciences’ MCED test (Cancerguard) to assess the overall sensitivity and specificity of the MCED test in a Japanese population. The secondary objective is to evaluate test performance across cancer types and stages. Methods: The study will include Japanese participants aged 45-84 years. Participants must provide written informed consent prior to providing a peripheral blood sample. A cancer cohort of approximately 1,000 participants with newly diagnosed confirmed cancer will be included in the study. Cancer cases will be recruited to obtain a diverse representation of cancer types and stages while also considering prevalence rates by cancer type. Emphasis will be placed on the 16 cancers with the highest incidence in Japan: lung, gastric, prostate, colorectal, breast, liver, pancreatic, bladder/renal pelvis, non-Hodgkin lymphoma, esophageal, kidney, uterine, cervical, ovarian, biliary tract, and head and neck. Approximately 1,000 non-cancer control participants will be included in the study, corresponding to the age and gender distribution from current population estimates reported by the Statistics Bureau of Japan. These participants will have no known cancer at enrollment, with status confirmed based on up-to-date routine cancer screening consistent with Japanese national cancer screening programs and subsequently through a 12-month follow-up after enrollment. Participants are enrolled at clinical sites in Japan, including cancer screening centers affiliated with the Japan Cancer Society. Whole blood will be collected at study sites in LBgard tubes, shipped to a local laboratory, processed to isolate the plasma and buffy coat, and then frozen. The frozen plasma and buffy coat samples will be shipped to the Exact Sciences clinical laboratory (Madison, WI, USA) for analysis. Approximately 300 non-cancer control samples and ~50 cancer case samples will undergo interim testing to assess test logistics and preliminary performance. No protocol modifications or enrollment pauses will occur based on interim testing results. Final testing will occur once all participants have been enrolled. The study duration is expected to be approximately 24 months. This study is funded by Exact Sciences Corporation. Clinical trial information: UMIN000059407.