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

NCT ID: NCT02756637

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 634 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-11-30

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.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Prognostic

Patients with NLR who completed curative therapy (surgery with or without chemo)

No interventions assigned to this group

Predictive

Patients with NLR who were assigned to a trial arm (chemo or no chemo)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

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

Exclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Christodouleas, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 15816

Identifier Type: -

Identifier Source: org_study_id