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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Long Cui

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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XHGC 001

Identifier Type: -

Identifier Source: org_study_id

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