跳至主要内容
临床试验/NCT05504161
NCT05504161Unknown不适用

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

Yonsei University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年12月30日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验