NCT00826579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2000

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

8.7 years

First QC Date

January 13, 2009

Last Update Submit

March 11, 2015

Conditions

Colonic Neoplasms

Keywords

Sentinel lymph nodeLymph node analysisBone marrow analysis

Outcome Measures

Primary Outcomes (1)

  • To assess the extent of upstaging due to the SLN procedure for colon cancer.

    1 month

Secondary Outcomes (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.

    1 month, 3 and 5 years after surgery

Study Arms (1)

Colon cancer

EXPERIMENTAL

Colon cancer patients of all stages

Procedure: Sentinel lymph node procedureProcedure: Bone marrow aspiration

Interventions

Sentinel lymph node procedurePROCEDURE

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.

Also known as: Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH
Colon cancer
Bone marrow aspirationPROCEDURE

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.

Colon cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior intrabdominal tumor surgery
  • Other preexisting malignancies
  • Hypersensitivity/allergy to dye (isosulfan blue)
  • Pregnancy
  • Breast-feeding
  • No patient's informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Carsten T. Viehl, MD

Basel, 4031, Switzerland

Location

Urban Laffer, MD

Biel, 2501, Switzerland

Location

Markus Zuber, MD

Olten, 4600, Switzerland

Location

Related Publications (2)

  • Weixler 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: 28593306DERIVED

  • Viehl 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: 23354923DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

iso-sulfan blue

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Carsten T. Viehl, MD

    aktuell: Spitalzentrum Biel-Bienne

    PRINCIPAL INVESTIGATOR

  • Markus Zuber, MD

    Kantonsspital Olten

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 22, 2009

Study Start

May 1, 2000

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

CH(3)