NCT01911988

Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Timeline

• Start date: 2013-06-01
• Primary completion: 2020-12-01
• First posted: 2013-07-30
• Last updated: 2016-10-20

Locations

1 site across 1 country: China