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Completed

NCT Number: NCT02756637

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

  • 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
  • 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).

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 26 years

    Number of participants who survived at 26 years are reported.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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