Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer
NCT ID: NCT01911988
Last Updated: 2016-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1 participants
OBSERVATIONAL
2013-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colon&Rectal Stage II /Stage III
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ECOG 0-2
* Age 18-90
* Gender both
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Long Cui
Director
Principal Investigators
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Long Cui, MD, PhD
Role: STUDY_CHAIR
Medical Center of Colon&Rectal Cancers, Shanghai Xinhua Hospital affiliated to Shanghai Jiaotong University
Locations
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Medical Center of Colon&Rectal Cancers
Shanghai, , China
Countries
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Other Identifiers
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XHGC 001
Identifier Type: -
Identifier Source: org_study_id
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