Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Disease Free Survival
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer
Detailed Description
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.
Investigators
Long Cui
Director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Clinically /Pahohistologically diagnosed as stageII/III CRC
- •Age 18-90
- •Gender both
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Disease Free Survival
Time Frame: 5 years
The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.
Secondary Outcomes
- 5 years overall survival(5 years or the time of death)