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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756637
• Other study ID #: UPCC 15816
• Status: Completed
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: August 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Number of participants who survived at 26 years are reported.	26 years