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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05946369
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Cancer; Urinary Bladder Neoplasm; BCG; Trans Urethral Resection of a Bladder Tumor; Non-Muscle Invasive Bladder Urothelial Carcinoma	Diagnostic Test: Neutrophil to lymphocyte ratio

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 Design

• Study Type: Observational
• Actual Enrollment: 96 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Preoperative Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Neutrophil to lymphocyte ratio less than 3 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
Neutrophil to lymphocyte ration more than or equal 3 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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams university	Cairo		Egypt	11367

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Maher Gamil Ahmed Higazy, principle investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05946369
• Other Study ID Numbers: MS 475/ 2021
• First Posted: Jul 14, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Study Results

No Results Posted as of Jul 18, 2023