Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT02756637
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Results First Submitted: 2016-12-02
• Results First Submitted QC: 2017-02-27
• Results First Posted: 2017-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

1. SWOG 8710 original trial inclusion criteria included:

   • Node-negative, muscle-invasive transitional cell carcinoma of the bladder, T2-T4aN0M0 per the AJCC 4th edition staging manual.
   • SWOG performance status of 0 or 1
   • Adequate organ function by lab criteria (WBC > 4,000 cells/mm3, platelets >150,000 cells/mm3, creatinine <1.5 md/dL (men) or <1.3 md/dL (women), baseline liver tests < 2 times normal limits)

2. Inclusion criteria for this secondary analysis are:

   • Eligible for original SWOG 8710 trial
   • Had complete blood count with differential prior to first treatment (radical cystectomy or NAC).

Exclusion Criteria

1. SWOG 8710 original trial exclusion criteria included:

   • No age restrictions
   • Previous or concomitant malignancy other than bladder cancer or basal cell skin cancer
   • Prior pelvic radiation
   • Metastatic or incurable disease
   • Laboratory values exceeding those detailed in 3.1.c

2. Exclusion criteria for this secondary analysis are:

   • Ineligibility for the original SWOG 8710 study
   • Lack of complete blood count with differential prior to first treatment (cystectomy or NAC).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	26 years	Number of participants who survived at 26 years are reported.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States