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.
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
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.
The study population consists of female patients aged 19 to 79 who have been histologically diagnosed with either endometrial cancer or cervical cancer at Asan Medical Center. This cohort includes patients across various stages of the disease who are scheduled to undergo or have completed standard-of-care treatments, such as radical surgery, adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy (CCRT). The population is designed to represent a real-world clinical setting of gynecologic oncology patients to evaluate the effectiveness of MRD monitoring in predicting recurrence and survival outcomes.
Cohort
Prospective
Serial blood collection for MRD testing
GeneticParticipants 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.
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.
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.
Overall Survival (OS)
Comparison of the overall survival rate between patients with MRD-positive and MRD-negative results using the Hazard Ratio (HR).
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