Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in pancreatic cancer

  1. Xutai Li
  2. Pengwu Zhang
  3. Hui Zhang
  4. Chen Sun
  5. Zhenjian Ge
  6. Wenkang Chen
  7. Yingqi Li
  8. Shengjie Lin
  9. Wuping Wang
  10. Siwei Chen
  11. Yutong Wu
  12. Huimei Zhou
  13. Wei Li
  14. Fei Feng
  15. Zewei Lin
  16. Yongqing Lai
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Abstract

Pancreatic cancer is a serious threat to human health. Enhanced CT is widely used in the diagnosis of pancreatic cancer. However, false-positive results of enhanced CT will bring unnecessary mental pain, expensive examination costs, physical injuries, and even adverse consequences such as organ removal and loss of function; while false-negative results of enhanced CT bring delayed treatment, and patients will thus have to bear the adverse consequences of poor prognosis, high treatment costs, poor quality of life, and short survival period. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive and false-negative rates of enhanced CT in pancreatic tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in pancreatic cancer.

Patients and methods

62 subjects (malignant group, n=37; benign group, n=25) were finally included in this study. Remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively.

Results

YiDiXie™-SS had a sensitivity of 100% (95% CI: 88.6% - 100%; 30/30) and a specificity of 66.7% (95% CI: 30.0% - 94.1%; 4/6) in pancreatic enhanced CT-positive patients. This means that the application of YiDiXie™-SS reduces the false-positive rate of pancreas-enhanced CT by 66.7% (95% CI: 30.0% - 94.1%; 4/6) with essentially no increase in malignancy leakage. YiDiXie™-HS had a sensitivity of 85.7% (95% CI: 48.7% - 99.3%; 6/7) and a specificity of 84.2% (95% CI: 62.4% -92.5%; 16/19) in enhanced CT-negative patients. This means that YiDiXie ™ -HS reduces the false-negative enhancement CT rate by 84.2% (95% CI: 62.4% -92.5%; 16/19). YiDiXie™-D has a sensitivity of 33.3% (95% CI: 19.2% - 51.2%; 10/30) and a specificity of 100% (95% CI: 61.0% - 100%; 6/6) in patients with positive enhancement CT. This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 100% (95% CI: 61.0% - 100%; 6/6).

Conclusion

YiDiXie ™ -SS YiDiXie ™ -SS significantly reduces the false-positive rate of pancreatic enhanced CT with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS significantly reduces the false-negative rate of pancreatic enhanced CT. YiDiXie™-D significantly reduces the false-positive rate of pancreatic enhanced CT. The YiDiXie™ test has significant diagnostic value in pancreatic cancer, and is expected to solve the problem of “excessive false-positive rate of enhanced CT” and “excessive false-negative rate of enhanced CT” in pancreatic tumors.

Clinical trial number

ChiCTR2200066840.

Article activity feed

  1. Version published to 10.1101/2024.07.30.24311246v2 on medRxiv
  2. Version published to 10.1101/2024.07.30.24311246v1 on medRxiv