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

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ClinicalTrials.gov Identifier: NCT02756637
Recruitment Status : Completed
First Posted : April 29, 2016
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease
Bladder Cancer

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Study Type : Observational
Actual Enrollment : 634 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710
Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort
Prognostic
Patients with NLR who completed curative therapy (surgery with or without chemo)
Predictive
Patients with NLR who were assigned to a trial arm (chemo or no chemo)



Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 26 years ]
    Number of participants who survived at 26 years are reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects enrolled in SWOG 8710
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756637


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: John Christodouleas, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02756637     History of Changes
Other Study ID Numbers: UPCC 15816
First Posted: April 29, 2016    Key Record Dates
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases