Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Detection rate
研究概览
简要总结
Circulating tumor DNA (ctDNA) may help detect and prognosis-stratify patients with endometrial cancer. Both cervical swab-based genomic DNA (gDNA) and whole blood-based ctDNA can be utilized for this goal. Our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctDNA from patients with endometrial cancer. These samples will be collected prospectively, and prior to staging operation. Samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. Variants called by next generation sequencing were classified into four-tiers based on ASCO/AMP system. These initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. Additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. Clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, over 19 years of age
- •Patients with endometrial cancer or benign gynecological diseases
排除标准
- •Patients in pregnancy
- •Patients being treated for cancer of other organs, including gynecological cancer.
- •Patients who has difficulty reading and understanding Korean.
- •The tester's determination that the patient will not be able to comply with the clinical trial procedures.
- •Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
结局指标
主要结局
Detection rate
时间窗: Detection rate based on two different modalities at the time of surgery.
We aim to compare the ctDNA mutation detection rate based on cervical swab and whole blood at the time of surgery.
次要结局
未报告次要终点
