Influence of Tumor Associated Immunity on the Number of Lymph Node Retrieved After Colorectal Cancer Surgery (Preliminary Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629524
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Hypothesis of this study is that increased immunity of primary tumor affects the increased number of lymph node retrieved. This study investigates whether immunity-related cytokine expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph node retrieved in colorectal cancer patients.

Condition or disease
Colorectal Cancer

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Colorectal cancer patients
Colorectal cancer patients undergoing elective colorectal resection

Primary Outcome Measures :
  1. Association between immune related cytokine and number of lymph nodes retrieved. [ Time Frame: 2 months after surgery ]
    Immunity related cytokine - IL-12, IFN-r, GM-CSF, IL-4, TNF-a, IL-6, IL-8, IL-10, TGF-b1, CXCR4, SDF1, HGF, VEGF - expression is assessed using Bioplex assay. Patient serum is taken one day before surgery. Primary tumor and colonic mucosal tissue are taken just after surgery. Bioplex assay is performed after patients' enrollment

Biospecimen Retention:   Samples Without DNA
Serum and postoperative specimen

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer patients diagnosed with clinically TNM I, II, or III stage

Inclusion Criteria:

  • 1. Histologically confirmed colorectal cancer 2. Non-metastatic cancer (cTNM I, II, or III) 3. Over 20 years of age 4. Curative resection (R0)

Exclusion Criteria:

  • 1. Patient with distant metastasis 2. History of chemotherapy or radiation therapy for malignancy 3. Patient receiving immunosuppressive or anti-inflammatory treatment 4. Hereditory colorectal cancer 5. Preoperative chemoradiation therapy for colorectal cancer 6. Pregnancy 7. Emergency

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01629524

Korea, Republic of
Wonji Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01629524     History of Changes
Other Study ID Numbers: 2012-08
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases