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

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

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colon&Rectal Stage II /Stage III<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral immune cells, Colorectal Cancers, Stage II/ Stage III, Recurrence, Metastasis