NCT04714814Unknown不适用
a Multi-omics Cohort Study of Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- recurrence or metastasis provened by imageologic diagnosis (PFS)
研究概览
简要总结
This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer.
详细描述
Stage Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 200 colorectal cancer cases( at least 160 stage Ⅲ cases,40 stage Ⅳ（synchronous metastasis）).Stage Ⅱ is a nested case-control study. 200 eligible cases enrolled in phaseⅠwill be followed up for 5 years to record recurrence, metastasis and to collect biospecimen . Each case with the study outcome will be matched with the corresponding control according to the proportion of 1:1 according to age, sex and other conditions, and further analysis will be made.
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
- 否
入选标准
- •Baseline population (stage III colorectal cancer) inclusion criteria:
- •Physical condition (ECOG) score ≤
- •Colorectal adenocarcinoma was confirmed by histopathology.
- •No family history of hereditary tumor.
- •Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥
- •Preoperative clinical stage is stage III.
- •Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- •Enough primary surgical or biopsy tissues for examination.
- •Enough peripheral blood samples for examination.
- •Agree to sign informed consent to participate in this project.
- •Baseline population (stage Ⅳ colorectal cancer) inclusion criteria:
- •Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
- •Not yet received antineoplastic therapy.
- •Baseline imaging evaluation shows at least one measurable focus.
- •Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.
- •Enough peripheral blood samples for examination.
- •Expected survival time ≥ 3 months.
- •Provide information such as demography, current medical history or current tumor disease, pathological diagnosis and staging of tumor, physical status of ECOG, radiographic evaluation of tumor, etc.
- •Agree to sign informed consent to participate in this project.
- •Metastasis colorectal cancer cohort study inclusion criteria:
- •Physical condition (ECOG) score ≤
- •Colorectal adenocarcinoma was confirmed by histopathology.
- •No family history of hereditary tumor.
- •Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥
- •Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III.
- •Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- •Enough primary surgical or biopsy tissues for examination.
- •Enough peripheral blood samples for examination.
- •Agree to sign informed consent to participate in this project.
排除标准
- •Baseline population (stage III colorectal cancer) exclusion criteria:
- •Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- •Postoperative pathological stage was confirmed as stage II.
- •Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
- •Diagnosed with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- •Having mental illness or other serious cardiovascular diseases.
- •Pregnancy or lactation or planned pregnancy within one year.
- •Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
- •Baseline population (stage Ⅳcolorectal cancer) exclusion criteria:
- •Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
- •Nervous system metastasis.
- •Complicated with other malignant tumors.
- •Having poorly controlled chronic concomitant diseases that affect the prognosis.
- •Any complication that may affect the results of the study .
- •Metastasis colorectal cancer cohort study exclusion criteria:
- •Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- •Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
- •Diagnoses with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- •Having mental illness or other serious cardiovascular disease.
- •Pregnancy or lactation or planned pregnancy within one year.
- •Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
结局指标
主要结局
recurrence or metastasis provened by imageologic diagnosis (PFS)
时间窗: May 31, 2023
tumor metastasis or progression occurred during the enrolment period
次要结局
未报告次要终点
研究者
研究点 (1)
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