An observational study in Urinary Bladder Cancer, Urinary Bladder Neoplasm and BCG, sponsored by Ain Shams University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Ain Shams University · Observational
There is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder).
In this study, the investigators will link the Neutrophils to Lymphocytes ratio to the response to intravesical BCG therapy post trans-urethral resection of urinary bladder tumors for the non-invasive urinary bladder tumors.
The gold standard treatment for non-invasive urinary bladder tumors is by transurethral resection of bladder tumor (TURBT) and a re-TURBT when indicated, followed by adjuvant intravesical immunotherapy (BCG). However, the recurrence and progression rates of non-muscle invasive bladder cancer (NMIBC) for 5 years range from 31% to 78% and from 1% to 45%, respectively.
To improve personalized care, prognostic models have been developed to help in prediction of the high-risk patients and recurrence helping in clinical and therapeutic decision-making. These models are based on standard clinic-pathological features such as T stage, grade, multifocality, sex, tumor diameter, recurrence rate, and concomitant carcinoma in situ.
According to the current theories, the systemic inflammatory response triggered by cancer leads to relative neutrophilia and lymphocytopenia, creating a pro-oncogenic inflammatory condition. An elevated NLR (Neutrophil to lymphocyte ratio) implies that cell-mediated immunity is impaired and systemic inflammation is increased in inflammatory processes. Among patients with non-invasive urinary bladder tumors, an elevated NLR (Neutrophil to lymphocyte ratio) was described in the literature to be associated with advanced pathologic stage, invasiveness, and bad prognosis.
The study aims to assess the role of preoperative Neutrophils to Lymphocytes ratio as a predictor for the response to BCG in patients with non-muscle invasive bladder cancer in patients following trans-urethral resection of bladder tumor (TURBT).
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 96 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Patients with intermediate and high-risk group of non-muscle invasive urothelial tumor will be included in our study.
They will go through detailed history taking, general and local examinations. Routine Labs (specially CBC with Differential Count) preoperatively will be done to all patients during the surgery workup.
Histopathology report of the first resection and another one of the check cystoscopy to confirm the primary diagnosis.
BCG course ( once weekly for 6 weeks) 2-6 weeks after resection as an induction course. Then maintaince doses for 1-3 years based on the European Association of Urology recommendations.
Follow up cystoscopy will be scheduled based on the European association of Urology schedule for intermediate and high risk groups.
Exclusion Criteria:
Patients are classified into 2 groups according to NLR \< or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure
Diagnostic Test: Neutrophil to lymphocyte ratio
Patients are classified into 2 groups according to NLR \< or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure
Diagnostic Test: Neutrophil to lymphocyte ratio
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient
BCG failure
evaluation of tumor recurrence or progression post BCG intravesical instillation in our study population and draw up and correlation between BCG failure and Neutrophil to lymphocyte ratio
Time frame: 3 years following tumor resection and BCG instillation
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University