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

Colorectal Cancer Clinical Trial

— PICC-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01911988
• Other study ID #: XHGC 001
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2013
• Last updated: October 19, 2016
• Start date: June 2013

Study information

• Verified date: October 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	Medical Center of Colon&Rectal Cancers	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.	5 years	Yes
Secondary	5 years overall survival	the time from resection to the time of death from any cause	5 years or the time of death	Yes