NCT07068529招募中不适用
Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-CRC
Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年6月15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
- 250
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •**Healthy Controls:**
- •Age ≥ 18 years;
- •Signed informed consent and willingness to participate in the project.
- •**Colorectal Cancer:**
- •Age ≥ 18 years;
- •Performance status (ECOG) score ≤ 1;
- •Histopathologically confirmed colorectal adenocarcinoma;
- •No family history of hereditary cancer;
- •No prior anti-tumor treatment;
- •Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
- •Availability of peripheral blood samples that meet submission requirements;
- •Willingness and ability to sign the informed consent form to participate in the study.
排除标准
- •**Healthy Controls:**
- •Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome);
- •History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
- •Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
- •History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
- •Regular use of immunosuppressive drugs within the past 6 months;
- •Long-term use of other medications that may affect metabolism, such as hormones;
- •Inability or unwillingness to cooperate with follow-up visits and related examinations;
- •Inability to eat normally or requiring medications or enemas for bowel movements;
- •Presence of psychiatric disorders or other severe cardiovascular diseases;
- •Pregnant, breastfeeding, or planning to become pregnant within the next year;
- •Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.
- •**Colorectal Cancer:**
- •A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
- •Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
- •Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
- •History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
- •Presence of poorly controlled chronic comorbidities that may affect prognosis;
- •Presence of psychiatric disorders or other severe cardiovascular diseases;
- •Pregnant, breastfeeding, or planning to become pregnant within the next year;
- •Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
- •Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.
结局指标
主要结局
Overall survival
时间窗: 3 years
The time from the start of treatment to death due to any cause.
Disease-Free Survival
时间窗: 3 years
Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease.
次要结局
- Assessment of Important Metabolic Biomarkers(3 years)
- Hazard Ratio(3 years)
- Positive Predictive Value(3 years)
- Negative Predictive Value(3 years)
- Recurrence and Metastasis Rate(3 years)
- Cancer-Related Mortality(3 years)
- Time to Recurrence and Metastasis and Specific Sites(3 years)
研究者
研究点 (1)
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