Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer

N/ANot Yet RecruitingNCT07382505

Asan Medical Center600 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Interventions

Serial blood collection for MRD testingGENETIC

Participants will undergo serial peripheral blood collection (approximately 20 mL per visit) at predefined clinical milestones: baseline (diagnosis), post-operative (2-4 weeks after surgery), post-adjuvant therapy (2-4 weeks after completion of chemotherapy or CCRT), and during follow-up surveillance (every 3 months for up to 24 months). The collected blood will be used to perform Minimal Residual Disease (MRD) testing by analyzing circulating tumor DNA (ctDNA). Archival tumor tissue (FFPE blocks or slides) from initial diagnosis or surgery will also be collected to identify patient-specific somatic mutations for the MRD assay. This study is observational and does not involve any changes to the patient's standard of care or medical treatment.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed endometrial cancer or cervical cancer. * Scheduled for or completed standard treatment (Surgery, Adjuvant therapy, or CCRT). * Provision of written informed consent for study participation and biospecimen collection Exclusion Criteria: * Synchronous other malignancies (cancer requiring treatment within the last 5 years). * Persistent infection or bleeding tendency that makes repeated blood collection unsafe. * Inability to follow-up or communicate (e.g., due to geographic or cognitive reasons). * Any condition that the principal investigator deems inappropriate for the study.

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Evaluation of the association between MRD status (detected vs. not detected) and the risk of recurrence or death. MRD will be analyzed as a time-dependent covariate in a Cox proportional hazards model.

Time frame: From the date of enrollment until the date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 48 months.

Secondary Outcomes

Sensitivity and Specificity of MRD Assay

Evaluation of the diagnostic performance metrics, including sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of ctDNA-based MRD testing for predicting clinical recurrence.

Time frame: Assessed at specific landmarks (e.g., post-surgery and completion of adjuvant therapy) up to 48 months.

Overall Survival (OS)

Comparison of the overall survival rate between patients with MRD-positive and MRD-negative results using the Hazard Ratio (HR).

Time frame: From the date of enrollment until the date of death from any cause, assessed up to 48 months.