Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558019
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence a Prospective Multicenter Observational Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ovarian cancer is the third most common malignant tumor in Chinas female reproductive system in terms of incidence rate and the first in terms of mortality Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial ovarian cancer The efficacy rate of first-line platinum combined with taxus chemotherapy is more than 80 and more than half of them reach complete remission CR However even if advanced patients reach CR 50 -70 still relapse with a median disease-free interval of 16 months Most patients lack typical symptoms when they relapse The sensitivity of CA125 in monitoring recurrence is poor 43-74 which means that more than 25 of ovarian cancer patients cannot detect recurrence in a timely manner during follow-up Therefore more sensitive biomarkers are needed for monitoring ovarian cancer recurrence after treatment More and more studies have explored the application value of extracellular vesicle technology in the diagnosis and treatment of ovarian cancer including auxiliary diagnosis prognosis monitoring etc China already has an approved exosome ovarian cancer diagnostic product by the National Medical Products Administration namely the Ovarian Cancer Diagnostic Score OCS product based on exosome technology which is also the worlds first exosome technology diagnostic kit for ovarian cancer Clinical trial data shows that OCS products have demonstrated excellent performance in distinguishing between benign and malignant ovarian tumors Under high specificity 902 it has a higher sensitivity than serum CA125 reaching 955 95 CI 927 -973 and has a sensitivity of 897 in the diagnosis of stage I ovarian cancer OCS exhibits better sensitivity than CA125 especially in early ovarian cancer suggesting that OCS may be a better tool for monitoring recurrence in ovarian cancer patientsThe main purpose of this study is to establish an OCS scoring ovarian cancer recurrence prediction and monitoring model based on exosome technology providing an effective tool for clinical ovarian cancer recurrence prediction and monitoring Secondly we hope to explore the correlation between OCS score and tumor staging chemotherapy sensitivity PFS OS indicators etc and determine the performance of recurrence prediction models in different subgroups such as different pathological subtypes of ovarian cancer and different treatment methods
Detailed Description:
This research subjects are patients with epithelial ovarian cancerThe training set adopts case-control analysis using the PASS software Test for Two Related Proportions in a Matched Case Control Design module Setting α005 β01 assuming P010 OR4 and a 11 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 50253 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 α005 and β02 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 50113 patients Assuming a specificity of not less than 90 α005 β02 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None