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

Urinary Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946369
• Other study ID #: MS 475/ 2021
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• BCG
• Non-Muscle Invasive Bladder Urothelial Carcinoma
• Urinary Bladder Cancer
• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Neutrophil to lymphocyte ratio
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years following tumor resection and BCG instillation