Prospective Cohort to Evaluate the Prognostic and Early-Recurrence Detection Performance of Blood-based Minimal Residual Disease (MRD) Testing in Endometrial and Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
endometrial cancer cohort
patients diagnosed with endometrial cancer
干预措施: Serial blood collection for MRD testing (Genetic)
cervical cancer cohort
patients diagnosed with cervical cancer
干预措施: Serial blood collection for MRD testing (Genetic)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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.
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.
次要结局
- Sensitivity and Specificity of MRD Assay(Assessed at specific landmarks (e.g., post-surgery and completion of adjuvant therapy) up to 48 months.)
- Overall Survival (OS)(From the date of enrollment until the date of death from any cause, assessed up to 48 months.)
研究者
Jeong-Yeol Park, MD, PhD
professor
Asan Medical Center