A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
1 other identifier
observational
761
1 country
1
Brief Summary
A prospective observational study to re-establish a new prognostic model for predicting the outcome in patients with non-muscle invasive bladder cancer (NMIBC) using the current recommendation regimen for intermediate and high risk groups and including all potential and highly prognostic factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 16, 2017
May 1, 2017
2.5 years
March 15, 2017
May 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Construct a new prognostic model for the prediction of recurrence and progression of NMIBC
Outcome Measure by counting and cmparing number of patients surviving for two year without tumor recurrence or progression to muscle invasive bladder cancer
2 years
Secondary Outcomes (2)
cancer-specific survival (CSS) after treatment of NMIBC
5 years
overall survival (OS) after treatment of NMIBC
5 years
Eligibility Criteria
Eligible patient presented with NMIBC will be asked to participate in this study and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
You may qualify if:
- Patient with NMIBC
You may not qualify if:
- Refuse to complete study requirements
- Contraindication to BCG therapy
- Muscle invasive disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Mansora, Aldakahlia, 35516, Egypt
Biospecimen
bladder biopsy of TURBT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Mosbah, MD
Urology and Nephrology Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Msc
Study Record Dates
First Submitted
March 15, 2017
First Posted
April 20, 2017
Study Start
May 15, 2017
Primary Completion
December 1, 2019
Study Completion
April 1, 2022
Last Updated
May 16, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
meta-analyses by contact the Prof. Ahmed Mosbah MD (Study Chair)