Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer (PICC-1)

The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 2000092
    • Medical Center of Colon&Rectal Cancers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stage II /Stage III Colorectal Patients

Description

Inclusion Criteria:

• Clinically /Pahohistologically diagnosed as stageII/III CRC
• ECOG 0-2
• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Colon&Rectal Stage II /Stage III

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 years overall survival	the time from resection to the time of death from any cause	5 years or the time of death

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Long Cui, MD, PhD, Medical Center of Colon&Rectal Cancers, Shanghai Xinhua Hospital affiliated to Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 27, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Recurrence; Metastasis; Colorectal Cancers; Peripheral immune cells; Stage II/ Stage III
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: XHGC 001