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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of participants who survived at 26 years are reported. | 26 years |
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Inclusion Criteria:
SWOG 8710 original trial inclusion criteria included:
Inclusion criteria for this secondary analysis are:
Exclusion Criteria:
SWOG 8710 original trial exclusion criteria included:
Exclusion criteria for this secondary analysis are:
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Subjects enrolled in SWOG 8710
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| Name | Affiliation | Role |
|---|---|---|
| John Christodouleas, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prognostic Cohort | Patients with NLR who completed curative therapy (surgery with or without chemo) |
| FG001 | Predictive Cohort | Patients with NLR who were assigned to a trial arm (chemo or no chemo) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Prognostic Cohort: Eligible for SWOG 8710, had NLR and completed curative treatment Predicitive Cohort: Eligible for SWOG 8710, had NLR and were assigned to a trial arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prognostic Cohort | Patients with NLR who completed curative therapy (surgery with or without chemo) |
| BG001 | Predictive Cohort | Patients with NLR who were assigned to a trial arm (chemo or no chemo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Number of participants who survived at 26 years are reported. | Posted | Number | participants | 26 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prognostic Cohort | Patients with NLR who completed curative therapy (surgery with or without chemo) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Christodouleus | Abramson Cancer Center of the University of Pennsylvania | 215-662-2428 | John.Christodouleas@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Did not complete curative therapy |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
|
| 0 |
| 230 |
| 0 |
| 230 |
| EG001 | Predictive Cohort | Patients with NLR who were assigned to a trial arm (chemo or no chemo) | 0 | 263 | 0 | 263 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |