Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder 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.|
|ClinicalTrials.gov Identifier: NCT01395225|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : March 13, 2014
|Condition or disease|
|Bladder Cancer Transitional Cell Carcinoma|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Standardising an Approach for Analysis of Lymph Node Specimens From Radical Cystectomy With Pelvic Lymph Node Dissection Through the Use of an Organic Fat-emulsifying Agent|
|Study Start Date :||August 2011|
|Primary Completion Date :||April 2013|
|Study Completion Date :||December 2013|
There will be no separate cohorts in this study. All patients will have their specimens processed by conventional means and by the study method. The conventional means will be the control for the study method.
- Proportion of patients with lymph node metastasis on pathologic examination [ Time Frame: 2 years ]The primary outcome will be the proportion of patients found to have lymph nodes metastases on pathologic examination. Specifically, the difference in proportion of specimens found to contain nodal metastases using the fat-emulsifying protocol compared to the conventional lymph node processing will be analyzed.
- Total number of lymph nodes and lymph node metastasis [ Time Frame: 2 years ]Secondary outcome measures will be: the total number of lymph nodes and the total number of lymph node metastases counted by both techniques and the relationship between the size of lymph node and the presence of metastatic carcinoma.
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 ClinicalTrials.gov identifier (NCT number): NCT01395225
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Peter Black, MD||University of British Columbia|