Assessing the diagnostic performance of YiDiXie™ tests for detecting metastasis across multiple cancer types: A
Pengwu Zhang1, Chen Sun2, Zhenjian Ge3
1Department of Urology, Peking University Shenzhen Hospital, Shenzhen 518036, China; Institute of Urology, Shenzhen Peking University-The Hong Kong University of Science and Technology Medical Center, Shenzhen 518036, China; Shenzhen Clinical Research Center for Urology and Nephrology, Shenzhen 518036, China.
Background:
PET-CT is widely used to determine whether solid malignant tumors have metastasized. However, its significant limitations, such as high radioactivity, high cost, and the risk of allergic reactions to contrast agents, have clearly restricted its application. There is an urgent need to find a convenient, economical, and non-invasive diagnostic method to replace PET-CT for diagnosing cancer metastasis. The purpose of this study is to evaluate the diagnostic value of five YiDiXie™ tests in determining the metastatic status of multiple cancers.
Materials And Methods:
A total of 2276 subjects were ultimately included in this study (preoperative metastatic group, n = 102; preoperative non-metastatic group, n = 1875; postoperative metastatic group, n = 24; postoperative non-metastasis group, n = 275). Residual serum samples of the subjects were collected and tested using the YiDiXie™ all-cancer detection kit to evaluate the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-48, YiDiXie™-32, YiDiXie™-30, YiDiXie™-47, and YiDiXie™-41, respectively. The receiver operating characteristic (ROC) curve analysis was incorporated in this study.
Results:
In the preoperative group, YiDiXie™-48, YiDiXie™-32, and YiDiXie™-30 were unable to distinguish the metastatic group from the non-metastatic group due to their low specificity. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-47 were 97.1%, 82.9%, 5.7, and 0.04, respectively. The specificity of YiDiXie™-47 decreased as the stage of the non-metastatic group increased, and it had high sensitivity and high specificity for various cancer types. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-41 were 75.5%, 95.1%, 15.4, and 0.26, respectively. The specificity of YiDiXie™-41 decreased as the stage of the non-metastatic group increased, and it had high sensitivity and high specificity for various cancer types. Therefore, YiDiXie™-47 and YiDiXie™-41 can well distinguish the metastatic group from the non-metastatic group in the preoperative group. All five YiDiXie™ tests effectively distinguished the metastatic group from the non-metastatic group in the postoperative group.
Conclusion:
The combined application of YiDiXie™-47 and YiDiXie™-41 shows considerable effectiveness in diagnosing multiple cancer metastases before surgery, while the combined application of YiDiXie™-30 and YiDiXie™-41 demonstrates considerable effectiveness in monitoring cancer metastases after surgery. The combined application of YiDiXie™-47 and YiDiXie™-41 is expected to serve as a non-invasive alternative or complementary tool to PET-CT for preoperative diagnosis of multiple cancer metastases, and the combined application of YiDiXie™-30 and YiDiXie™-41 can effectively monitor cancer metastases after surgery.
Registry:
Chinese Clinical Trial Resgistry.
Clinical Trial Registration:
ChiCTR2200066840. Date of Registration:2022-12-19.
