NCT06291779招募中不适用
Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing Purine Metabolite (Hypoxanthine, Xanthine) in Urine
Ho-Seong Han1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urine
研究概览
简要总结
- This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
- It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population.
详细描述
- CubeBio and Seoul National University Bundang Hospital signed a joint technology development agreement to compare the analytical performance of existing analytical methods and purine metabolite analysis reagents developed by CubeBio.
- Through quantitative analysis of hypoxanthine and xanthine in the urine of normal people and pancreatic cancer patients, we plan to confirm the possibility of diagnosing pancreatic cancer using reagents for analyzing purine metabolites.
- Early diagnosis of pancreatic cancer is a key determinant of cure and survival rates, and impact on all aspects of cancer, including rate of progression, treatment, and prognosis.
- This study could change the paradigm of pancreatic cancer screening by evaluating the stability and accuracy of urinary purine metabolite analysis reagents.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
- •Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
- •Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
- •Patients with informed consent
排除标准
- •History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
- •Patient with Inflammatory disease(e.g. severe pancreatitis, cholangitis)
- •Patients with underlying diseases at high risk of general anesthesia
- •Other subject whom the investigator deems inappropriate
- •control group Inclusion Criteria included healthy individuals as well as patients with benign diseases.
- •Exclusion criteria for the control group included a previous cancer diagnosis within the past five years, active inflammatory diseases, borderline malignant pancreatic tumors, or a postoperative pathological finding of malignancy.
结局指标
主要结局
Urine
时间窗: 1 day
mean concentration of purine metabolites in urine
次要结局
未报告次要终点
研究者
Ho-Seong Han
Professor
Seoul National University Hospital
研究点 (1)
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