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The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Cancer Patients | Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical | The count of participants with hypogonadism (the level of serum testosterone used as a threshold). | 90 days post-RC surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy | The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold). | 30 days post-RC surgery |
| The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants are adult men undergoing RC for primary bladder cancer.
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Participants will be recruited from patients being treated at the University of Kansas Health System.Potiential patients will be recruited from the urology clinic, University of Kansas Cancer Center or during inpatient hospitalization.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Holzbeierlein, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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Patients were recruited from University of Kansas Medical Center Urology Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Bladder Cancer Patients | Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bladder Cancer Patients | Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
| 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 | Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical | The count of participants with hypogonadism (the level of serum testosterone used as a threshold). | Posted | Number | participants | 90 days post-RC surgery |
|
|
Patients were on trial for 3 months - this study was observational.
Patients were on trial for 3 months - this study was observational.
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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 | Bladder Cancer Patients | Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Glavin | University of Kansas Medical Center | 913-588-8721 | kglavin@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | Apr 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2017 | Nov 12, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold). |
| Immediately post-operatively RC surgery |
| The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy | The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold). | Baseline, prior to RC surgery |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy | The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold). | Posted | Count of Participants | Participants | 30 days post-RC surgery |
|
|
|
| Secondary | The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy | The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold). | Posted | Count of Participants | Participants | Immediately post-operatively RC surgery |
|
|
|
| Secondary | The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy | The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold). | Posted | Count of Participants | Participants | Baseline, prior to RC surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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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 |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |