Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:03 AM
Study NCT ID:
NCT07382505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Prospective Cohort to Evaluate the Prognostic and Early-Recurrence Detection Performance of Blood-based Minimal Residual Disease (MRD) Testing in Endometrial and Cervical Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
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:
This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer. The researchers will investigate whether MRD detection can identify cancer recurrence earlier than current standard imaging or clinical methods (providing a "lead time"). Participants will undergo blood collection at specific time points, including at diagnosis, after surgery, and during regular follow-up visits. The study will also assess the correlation between MRD status and survival outcomes, such as Relapse-Free Survival (RFS) and Overall Survival (OS). The goal is to establish a foundation for personalized treatment strategies based on molecular monitoring.
Detailed Description:
Despite standard treatments, a significant number of patients with endometrial and cervical cancer experience recurrence. Current monitoring relies on imaging (CT/MRI) and tumor markers (CA-125, SCC-Ag), which often detect recurrence only after a visible tumor mass has formed. This prospective cohort study evaluates the utility of ctDNA-based MRD testing as a high-sensitivity biomarker for early detection.
Study Population and Workflow: A total of 600 participants (300 with endometrial cancer and 300 with cervical cancer) will be enrolled. The study involves the following procedures:
Tumor Tissue Collection: Formalin-fixed paraffin-embedded (FFPE) tissue from surgery or biopsy will be collected for genomic profiling.
Serial Blood Collection: Peripheral blood samples (approximately 20ml) will be collected at:
Baseline (before surgery or CCRT)
Post-operative (within 4 weeks after surgery)
Post-adjuvant therapy (within 4 weeks after completion of chemotherapy or CCRT)
Surveillance (every 3 months for the first 2 years, then every 6 months)
MRD Analysis: Deep sequencing of plasma cell-free DNA (cfDNA) will be performed to track tumor-specific variants.
Objectives: The primary objective is to calculate the "lead time," defined as the interval between the first MRD-positive result and clinical/radiological recurrence. Secondary objectives include evaluating the sensitivity and specificity of the MRD assay and its association with RFS and OS. By comparing MRD dynamics with conventional biomarkers, this study seeks to determine if molecular monitoring can provide a more accurate assessment of a patient's prognosis and risk of relapse.
Study Population and Workflow: A total of 600 participants (300 with endometrial cancer and 300 with cervical cancer) will be enrolled. The study involves the following procedures:
Tumor Tissue Collection: Formalin-fixed paraffin-embedded (FFPE) tissue from surgery or biopsy will be collected for genomic profiling.
Serial Blood Collection: Peripheral blood samples (approximately 20ml) will be collected at:
Baseline (before surgery or CCRT)
Post-operative (within 4 weeks after surgery)
Post-adjuvant therapy (within 4 weeks after completion of chemotherapy or CCRT)
Surveillance (every 3 months for the first 2 years, then every 6 months)
MRD Analysis: Deep sequencing of plasma cell-free DNA (cfDNA) will be performed to track tumor-specific variants.
Objectives: The primary objective is to calculate the "lead time," defined as the interval between the first MRD-positive result and clinical/radiological recurrence. Secondary objectives include evaluating the sensitivity and specificity of the MRD assay and its association with RFS and OS. By comparing MRD dynamics with conventional biomarkers, this study seeks to determine if molecular monitoring can provide a more accurate assessment of a patient's prognosis and risk of relapse.
Study Oversight
Has Oversight DMC:
False
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?: