Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence

This research subjects are patients with epithelial ovarian cancer.The training set adopts case-control analysis, using the PASS software Test for Two Related Proportions in a Matched Case Control Design module. Setting α=0.05, β=0.1, assuming P0=10%, OR=4, and a 1:1 ratio between the case group and the control group, 101 cases need to be separately enrolled in the case group and the control group. The case group consists of patients who have achieved response to first-line treatment and experienced imaging recurrence. Therefore, 101 recurrence events need to be observed during the 18 month follow-up period. Assuming that the response rate to platinum based chemotherapy in first-line treatment is 80% and the recurrence rate at 18 months is 50%, they need to be enrolled in group 101 / 80% / 50%=253 cases. The control group consisted of at least 101 patients who achieved CR with first-line treatment and had no recurrence of OCS imaging during follow-up testing. Assuming a CR rate of 70% with first-line treatment, 145 patients need to be enrolled. Therefore, the inclusion of 253 cases can meet the sample size requirements for both the case group and the control group. Considering a dropout rate of 15%, a total of 298 cases need to be enrolled. Evaluate the performance of the validation set in predicting recurrence. Assuming the sensitivity of predicting recurrence increases from 75% to 90%, with α=0.05 and β=0.2, 45 recurrence events are required. Assuming an 80% response rate to platinum based chemotherapy as first-line treatment and a 50% recurrence rate within 18 months, 45 recurrence events observed during the 18 month follow-up period need to be enrolled / 80% / 50%=113 patients. Assuming a specificity of not less than 90%, α=0.05, β=0.2, 179 patients are required for enrollment. Assuming a dropout rate of 15%, a total of 211 patients need to be included. Taking into account both sensitivity and specificity performance evaluation, a total of 211 patients were included in the validation set. This project will announce the findings and main achievements of this research through the publication of core Chinese papers and SCI indexed articles. In addition, this project will organize experts in the field to explore consensus and write guidelines, announcing the technical routes and application directions related to this research.