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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01629524
First received: June 25, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Association between immune related cytokine and number of lymph nodes retrieved. [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]
    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


Enrollment: 25
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colorectal cancer patients
Colorectal cancer patients undergoing elective colorectal resection

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Colorectal cancer patients diagnosed with clinically TNM I, II, or III stage

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629524

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01629524     History of Changes
Other Study ID Numbers: 2012-08
Study First Received: June 25, 2012
Last Updated: January 28, 2013
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013