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
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Basel, Switzerland
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 13, 2009 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | May 2000 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00826579 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer | ||||||||
| Official Title ICMJE | Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Colonic Neoplasms | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Colon cancer
Colon cancer patients of all stages
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00826579 | ||||||||
| Other Study ID Numbers ICMJE | Rhein4031 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Carsten T. Viehl, MD, University Hospital, Basel, Switzerland | ||||||||
| Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Basel, Switzerland | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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