Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341855
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-18
Brief Title:
Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with high-risk endometrial cancer may have MRD after surgical treatment which is a potential source of follow-up early recurrence and metastasis and because of its limited resolution traditional imaging including PETCT or laboratory methods may not be reliable to detect For patients with radical treatment the uncured population can be identified by the detection of MRD suggesting that patients may benefit from further intervention The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma
Detailed Description:
High-risk EC has a higher metastasis and recurrence rate accounting for only 20 of ECs but accounting for 48 of tumor-related mortality The prognosis of high-risk EC patients is still poor after standard treatment Among the indicators for monitoring the recurrence of high-risk EC the most commonly used tumor markers are CA125 and HE4 but these markers increase only in extrauterine metastasis and are less sensitive Tumor tissue biopsy is an invasive operation which can not reflect heterogeneity In addition continuous monitoring can not be achieved by one biopsy Therefore more sensitive personalized and easily monitored markers are needed to predict recurrence and prognosis in order to provide individualized treatment Patients after surgical treatment may have MRD which is a potential source of subsequent early recurrence and metastasis and because of its limited resolution traditional imaging including PETCT or laboratory methods may not be able to reliably detect For patients with radical treatment the uncured population can be identified by the detection of MRD suggesting that patients may benefit from further intervention CtDNA-MRD is a reliable predictive biomarker in EC The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial cancer using individualized customized strategy according to the mutation sites in tumor pathological tissue NGS detection results combined with cancer core genes customized probes for each patient To explore the feasibility of ctDNA-MRD in monitoring recurrence and evaluating prognosis of high-risk endometrial carcinoma According to the treatment and non-treatment groups of ctDNA-MRD-positive patients after adjuvant therapy to explore whether intensive treatment of ctDNA-MRD-positive patients with high-risk endometrial cancer after adjuvant therapy can significantly improve the survival benefits of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None