NCT06351384尚未招募不适用
Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform: a Prospective, Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients
研究概览
简要总结
This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.
Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for the colorectal cancer arm:
- •1.18-75 years old
- •Pathologically confirmed as colorectal adenocarcinoma
- •Medically able to receive radical surgery for colorectal cancer
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 1
- •Ability to provide a written informed consent
- •Inclusion Criteria for the healthy control arm:
- •1.18-75 years old
- •No clinically significant finding based on routine blood tests, urinalysis, CT, and ultrasound examinations
- •Ability to provide a written informed consent
- •Inclusion Criteria for the intestinal polyp arm:
- •1.18-75 years old
- •Pathologically confirmed as colorectal adenoma
- •Ability to provide a written informed consent
排除标准
- •History of other malignant tumors (excluding non-melanoma skin cancer).
- •Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
- •Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
- •Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
- •Prior blood transfusion (including blood components) within the past 2 weeks.
- •Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
- •Pregnancy women.
- •Acute inflammation or fever requiring drug escalation within 14 days prior to blood collection.
- •Inability to comply with study procedures such as blood collection and related examinations.
- •Deemed unsuitable for participation in the clinical trial by the investigator.
结局指标
主要结局
Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients
时间窗: 24 months
次要结局
未报告次要终点
研究者
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