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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University Hospital, Basel, Switzerland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00826579
First received: January 13, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Colonic Neoplasms
 Procedure: Sentinel lymph node procedure
Procedure: Bone marrow aspiration
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 month, 3 and 5 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2000
Estimated Study Completion Date: December 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colon cancer
Colon cancer patients of all stages
 Procedure: Sentinel lymph node procedure
After careful mobilization of the affected colon segment, isosulfan blue 1% is injected in vivo into the subserosa circumferentially around the tumor. Lymph nodes in the mesentery staining blue within the first minutes are marked as SLN. The procedure is followed by a resection of the affected colon segment with standard lymphadenectomy.
Other Name: Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH
Procedure: Bone marrow aspiration
Prior to surgery, bone marrow is aspirated from both iliac crests. Bone marrow aspirates are analyzed for the presence of occult metastatic colon cancer cells.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826579

Locations
Switzerland
Carsten T. Viehl, MD
Basel, Switzerland, 4031
Urban Laffer, MD
Biel, Switzerland, 2501
Markus Zuber, MD
Olten, Switzerland, 4600
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Carsten T. Viehl, MD University Hospital, Basel, Switzerland
Principal Investigator: Markus Zuber, MD Kantonsspital Olten, Switzerland
  More Information

No publications provided

Responsible Party: Carsten T. Viehl, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00826579     History of Changes
Other Study ID Numbers: Rhein4031
Study First Received: January 13, 2009
Last Updated: January 20, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Sentinel lymph node
Lymph node analysis
Bone marrow analysis

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

ClinicalTrials.gov processed this record on June 13, 2013