Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

Phase 1

Completed

• Conditions: Colonic Neoplasms
• Interventions: Procedure: Sentinel lymph node procedure; Procedure: Bone marrow aspiration

• Registration Number: NCT00826579
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colon cancer	Bone marrow aspiration	Colon cancer patients of all stages
Colon cancer	Sentinel lymph node procedure	Colon cancer patients of all stages

Primary Outcome Measures

Name	Time	Method
To assess the extent of upstaging due to the SLN procedure for colon cancer.	1 month

Secondary Outcome Measures

Name	Time	Method
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.	1 month, 3 and 5 years after surgery

Trial Locations

Locations (3)

Carsten T. Viehl, MD; 🇨🇭 Basel, Switzerland

Urban Laffer, MD; 🇨🇭 Biel, Switzerland

Markus Zuber, MD; 🇨🇭 Olten, Switzerland