Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer

Completed

• Conditions: BCG; Urinary Bladder Neoplasm; Urinary Bladder Cancer; Trans Urethral Resection of a Bladder Tumor; Non-Muscle Invasive Bladder Urothelial Carcinoma
• Interventions: Diagnostic Test: Neutrophil to lymphocyte ratio

• Registration Number: NCT05946369
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-14
• Last Update Submitted: 2023-07-15
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Patients with non-muscle invasive urothelial tumor of the urinary bladder

Exclusion Criteria

1. Concomitant malignancy.
2. Hematological disorders.
3. History of radiation or chemotherapy.
4. Concomitant infection or chronic inflammatory diseases.
5. Missing preoperative differential blood cell count.
6. Patients with low grade non muscle invasive Urinary baldder tumors.
7. Patients missing BCG after biopsy revealing NMIBC.
8. patients with non-compliance to BCG doses or the scheduled follow up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neutrophil to lymphocyte ratio less than 3	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
Neutrophil to lymphocyte ration more than or equal 3	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

Primary Outcome Measures

Name	Time	Method
BCG failure	3 years following tumor resection and BCG instillation	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

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt