Influence of Tumor Associated Immunity on the Number of Lymph Node Retrieved After Colorectal Cancer Surgery (Preliminary Study)
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 30, 2013
January 1, 2013
6 months
June 25, 2012
January 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Association between immune related cytokine and number of lymph nodes retrieved.
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
2 months after surgery
Study Arms (1)
Colorectal cancer patients
Colorectal cancer patients undergoing elective colorectal resection
Eligibility Criteria
Colorectal cancer patients diagnosed with clinically TNM I, II, or III stage
You may qualify if:
- \. Histologically confirmed colorectal cancer 2. Non-metastatic cancer (cTNM I, II, or III) 3. Over 20 years of age 4. Curative resection (R0)
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wonji Christian Hospital
Wŏnju, South Korea
Related Publications (1)
Kim YW, Kim SK, Kim CS, Kim IY, Cho MY, Kim NK. Association of serum and intratumoral cytokine profiles with tumor stage and neutrophil lymphocyte ratio in colorectal cancer. Anticancer Res. 2014 Jul;34(7):3481-7.
PMID: 24982357DERIVED
Biospecimen
Serum and postoperative specimen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 27, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 30, 2013
Record last verified: 2013-01