Abstract 1263: Interim results from a large-scale, prospective cohort study (JINLING) for multi-cancer early detection test in average-risk asymptomatic patients
Authors: Yang Shanshan , Bao Hua , Chen Xiaoxi , Wu Min , Tang Shiting , Yang Ruowei , Zhu Dongqin , Wu Xuxiaochen , Tang Wanxiangfu , Chang Shuang , He Peng , Xu Xiuxiu , Jiang Ya , Wu Shuyu , Liu Sisi , Zhang Xian , Wu Xue , Shao Yang 
Published: March 2024

Background: Previously, we reported that a multi-cancer early detection (MCED) test CanScan, which utilizes plasma cfDNA genome-wide fragmentomics-related features that can detect cancer signals and tissue of origin (TOO) signals across thirteen cancer types at 99% specificity in individuals with cancer. Here, we report the interim results of a first large-scale prospective clinical study in an asymptomatic population with average risk of cancer, the JINLING Cohort (NCT06011694).

Methods: This ongoing prospective clinical study is enrolling participants aged between 45 and 75 years old without cancer-related symptoms, initiated in June 2022. Each participant will undergo peripheral blood collection for CanScan test and annual routine physical exams once a year for three consecutive years, with an additional two years of follow-up. The primary objective of the study was to evaluate the diagnostic performance of the CanScan test in the early detection of multiple cancers. Secondary objectives include the evaluation of TOO accuracy, its efficiency and clinical utility, lead-time relative to clinical diagnosis, and participants' attitudes and adherence to this test compared to standard care screening methods.

Results: By June 2023, a total of 3724 participants with analyzable samples were included in the analysis. At the data cut off time of Sept 2023, 29 participants were clinically diagnosed with cancer, including 8 that were not in the 13 targeted cancer types. The majority of the cancers were found in the early stages (Stage I or II; 89.6%, 26/29). The CanScan test detected a cancer signal at a sensitivity of 55.2% (16/29; stage I: 10/21, 47.6%; stage II: 4/5, 80.0%; stage III: 2/3, 66.7%). For detected cancers, the prediction accuracy of the top predicted origin was 61.5% (95% CI [38.5%,84.6%]; stage I: 62.5% [5/8]; stage II: 1/3, 33.3%; stage III: 2/2, 100%). The accuracy was 84.6% (95% CI [61.5%,100.0%]; I: 87.5% [7/8]; II: 66.7% [2/3]; III: 100.0% [2/2]) when taking into account the top two predicted origins. Specificity was 97.9% (3619/3695) in non-cancer participants.

Conclusions: In this one-year interim analysis of the large-scale, prospective, clinical cohort study, we investigated the efficacy of the MCED test within an asymptomatic population with an average-risk of cancer. the CanScan test demonstrates capability in detecting a wide range of cancer types and predicting TOO at early stages, highlighting an exceptional level of sensitivity and accuracy while maintaining a high level of specificity. Therefore, the MCED test holds significant potential for early cancer screening in asymptomatic populations, potentially transforming preventative healthcare and improving patient outcomes.

Citation Format: Shanshan Yang, Hua Bao, Xiaoxi Chen, Min Wu, Shiting Tang, Ruowei Yang, Dongqin Zhu, Xuxiaochen Wu, Wanxiangfu Tang, Shuang Chang, Peng He, Xiuxiu Xu, Ya Jiang, Shuyu Wu, Sisi Liu, Xian Zhang, Xue Wu, Yang Shao. Interim results from a large-scale, prospective cohort study (JINLING) for multi-cancer early detection test in average-risk asymptomatic patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1263.