Clinical trial · Observational
A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
NCT01623258CI-TRIAL-00007211completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping. Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Standard of Care
- description
- Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging
- label
- Research
- description
- SOC with sentinel lymph node analysis
Primary outcomes (1)
- measure
- Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age 2. Primary, non-metastatic \[Stage I, II (localized, node negative), or III (localized, node positive)\] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology 3. Palpable mass at time of surgery 4. Capable of providing informed consent Exclusion Criteria: 1. Prior radiation or chemotherapy 2. Non-palpable colon tumor 3. Recurrent or Stage IV (metastatic) colon cancer 4. Unable to give informed consent
References
Publications (1)
- DERIVEDNissan A, Protic M, Bilchik AJ, Howard RS, Peoples GE, Stojadinovic A. United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer. Ann Surg. 2012 Sep;256(3):412-27. doi: 10.1097/SLA.0b013e31826571c8. PMID 22871988