Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer
详细描述
The investigators hypothesize differentiation of Peripheral Immune Cells(PIC) would result in resistance of chemotherapy and tumor local of metastatic recurrence.
The primary endpoint of this study is Disease Free Survival and the secondary endpoint is 5-year Overall Survival.
5ml peripheral blood will be sorted and counted through flow cytometry at the point of before primary treatment(surgery for colon cancers, neoadjuvant therapy for rectal cancers) , before the first chemotherapy postoperatively and 1 month after last chemotherapy.
Patients will be followed up with 3 monthly assessments in the first two years and 6 monthly assessments in the rest three years. Stratification factors include age , BMI , gender , tumor location , rectal or colon cancer stage,the chemotherapy (FOLFOX, XELOX, DeGramont or Capecitabine ),laparoscopic or laprotomy, anastomosis, concomitant medications and complications.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically /Pahohistologically diagnosed as stageII/III CRC
- •Age 18-90
- •Gender both
排除标准
- •Distant metastases noticed before or during surgery
- •History of malignant tumor disease
- •History of autoimmune diseases or immunodeficiencies
- •History of hematological disease
- •History of hepatic cirrhosis or Splenomegaly
- •History of chronic kidney disease
- •History of organ transplant
- •History of chronic inflammatory disease
- •Use of hematological drugs within 1 year prior to surgery
- •Use of immunodulatory drugs within 1 year prior to surgery
- •Use of chemotherapeutic drugs within 1 year prior to surgery
- •Long term Use of non-steroid anti-inflammatory drugs(>6 months)
- •Unable or Unwilling to undergo all the standard treatment
结局指标
主要结局
Disease Free Survival
时间窗: 5 years
The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.
次要结局
- 5 years overall survival(5 years or the time of death)
研究者
Long Cui
Director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine