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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01911988

Acronym

PICC-1

Enrollment

Registered

2013-07-30

Start date

2013-06-30

Completion date

Unknown

Last updated

2016-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Peripheral immune cells, Colorectal Cancers, Stage II/ Stage III, Recurrence, Metastasis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results