Trial record 2 of 52 for:
bladder cancer and columbia
Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer
This study is currently recruiting participants.
Verified October 2012 by University of British Columbia
Sponsor:
University of British Columbia
Collaborator:
Canadian Urologic Oncology Group
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01395225
First received: July 13, 2011
Last updated: October 23, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
When the bladder is removed for bladder cancer, pelvic lymph nodes (LN) are also removed. While the anatomic extent of this LN dissection is critical, the investigators often use the number of LN removed as a measure of the extent, which in turn is essential for determining the patient's further treatment and prognosis. The LN count, however, is also dependent on the pathologist's processing of the LN tissue, and the standards for this processing are poorly defined. The goal of this study is to establish a standardized method for processing and analyzing lymph node specimens. The investigators hypothesize that if an organic solvent is used to remove excess fat from the lymph nodes that the investigators will discover more clinically significant nodes in a more reproducible fashion when compared to the current method.
| Condition |
|---|
|
Bladder Cancer Transitional Cell Carcinoma |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Proportion of patients with lymph node metastasis on pathologic examination [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Total number of lymph nodes and lymph node metastasis [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All Patients
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients who undergo radical cystectomy with lymph node dissection at the Vancouver General Hospital (VGH) for clinical stage T1-4,N0,M0 bladder cancer will be invited to participate in this prospective study.
Criteria
Inclusion Criteria:
- All patients who undergo radical cystectomy with lymph node dissection at the Vancouver General Hospital (VGH) for clinical stage T1-4,N0,M0 bladder cancer will be invited to participate in this prospective study.
Exclusion Criteria:
- Inability to consent to study.
- Presence of concomitant malignancy.
- The use of neoadjuvant chemotherapy or radiation therapy.
- Prior pelvic surgery or radiation that may impair ability to perform adequate pelvic lymph node dissection.
- If a patient is enrolled but does not undergo a lymph node dissection (for example due to other intraoperative complications), the patient will be excluded from analysis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395225
Contacts
| Contact: Peter Black, MD | 780-475-4111 ext 55003 | pblack@interchange.ubc.ca |
| Contact: Michael J Metcalfe, MD | 778 808-2601 | michaelmetcalfe5@gmail.com |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Peter Black, MD, FRCP 604-875-4111 ext 55003 pblack@interchange.ubc.ca | |
| Sub-Investigator: Charles B Metcalfe, MD | |
| Sub-Investigator: Michael J Metcalfe, MD | |
| Sub-Investigator: Alan I So, MD | |
| Sub-Investigator: Martin E Gleave, MD | |
| Sub-Investigator: Blake C Gilks, MD | |
| Sub-Investigator: Edward C Jones, MD | |
Sponsors and Collaborators
University of British Columbia
Canadian Urologic Oncology Group
Investigators
| Principal Investigator: | Peter Black, MD | University of British Columbia |
More Information
Publications:
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01395225 History of Changes |
| Other Study ID Numbers: | H11-00748 |
| Study First Received: | July 13, 2011 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada Canada: Ministry of Health & Long Term Care, Ontario |
Keywords provided by University of British Columbia:
|
Fat Emulsifying Radical Cystectomy Pelvic Lymph Node Dissection Pathological Lymph Node Processing |
Bladder Cancer Transitional Cell Carcinoma Urothelial Cell Carcinoma |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma Carcinoma, Transitional Cell Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013