Clinical trial · Interventional
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
NCT00826579CI-TRIAL-00017121completedPhase 1 / Phase 2ClinicalTrials.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 study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk. Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.
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 |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone marrow aspiration | Procedure | — | UNRESOLVED |
| Sentinel lymph node procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Colon cancer
- description
- Colon cancer patients of all stages
- interventionNames
- Procedure: Sentinel lymph node procedure
- Procedure: Bone marrow aspiration
Primary outcomes (1)
- measure
- To assess the extent of upstaging due to the SLN procedure for colon cancer.
- timeFrame
- 1 month
Secondary outcomes (1)
- measure
- To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS.
- timeFrame
- 1 month, 3 and 5 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology. * Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded). * Patient's informed consent Exclusion Criteria: * Prior intrabdominal tumor surgery * Other preexisting malignancies * Hypersensitivity/allergy to dye (isosulfan blue) * Pregnancy * Breast-feeding * No patient's informed consent
References
Publications (2)
- DERIVEDWeixler B, Viehl CT, Warschkow R, Guller U, Ramser M, Sauter G, Zuber M. Comparative Analysis of Tumor Cell Dissemination to the Sentinel Lymph Nodes and to the Bone Marrow in Patients With Nonmetastasized Colon Cancer: A Prospective Multicenter Study. JAMA Surg. 2017 Oct 1;152(10):912-920. doi: 10.1001/jamasurg.2017.1514. PMID 28593306
- DERIVEDViehl CT, Guller U, Langer I, Laffer U, Oertli D, Zuber M. Factors influencing the success of in vivo sentinel lymph node procedure in colon cancer patients: Swiss prospective, multicenter study sentinel lymph node procedure in colon cancer. World J Surg. 2013 Apr;37(4):873-7. doi: 10.1007/s00268-013-1910-3. PMID 23354923