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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826579
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Study Start Date : May 2000
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826579

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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
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Principal Investigator: Carsten T. Viehl, MD aktuell: Spitalzentrum Biel-Bienne
Principal Investigator: Markus Zuber, MD Kantonsspital Olten
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00826579    
Other Study ID Numbers: Rhein4031
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Basel, Switzerland:
Sentinel lymph node
Lymph node analysis
Bone marrow analysis
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases