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

NCT05946369 | Completed

• 1 other identifier: MS 475/ 2021
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Cancer; Urinary Bladder Neoplasm; BCG; Trans Urethral Resection of a Bladder Tumor; Non-Muscle Invasive Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Neutrophil to lymphocyte ratio DIAGNOSTIC_TEST

Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient

Neutrophil to lymphocyte ratio less than 3; Neutrophil to lymphocyte ration more than or equal 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11367, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: May 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)