A Phase 1/2 interventional study of Sentinel lymph node procedure and Bone marrow aspiration in Colonic Neoplasms, sponsored by University Hospital, Basel, Switzerland. Completed at 3 sites in Switzerland. Per ClinicalTrials.gov, last updated 2015-03-12.
Sponsored by University Hospital, Basel, Switzerland · Phase 1/2, Interventional, and Diagnostic
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 192 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colon cancer patients of all stages
Procedure: Sentinel lymph node procedure · Procedure: Bone marrow aspiration
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
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.
To assess the extent of upstaging due to the SLN procedure for colon cancer.
Time frame: 1 month
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland