A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

Study Overview
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Brief Summary
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The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery. Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.

Official Title
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A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Genetic: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in whom pelvic lymph node dissection can be performed; Any male and/or female, who is ≥18 years of age; Pathological diagnosis of urothelial carcinoma of the bladder; Localized muscle-invasive disease defined as clinical stage T2-4aN0M0 tumors; Did not receive neoadjuvant therapy; No radiographic evidence of metastatic disease on CT scans of the abdomen and pelvis, chest x-ray, or bone scan; Informed consent before study participation Exclusion Criteria: Prior systemic chemotherapy; Prior radiation therapy; A history of another ongoing malignancy within the past 5 years other than basal cell carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood sample<br>the blood sample only collected prior to surgery | Genetic: Blood draw<br>* The research intervention is the blood sample only collected prior to surgery. Analyses of the data will be made by correlating the gene profile expression with the pathologic finding at surgery and the clinical status of the patients 2 years after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ability of a mononuclear-cell gene signature to predict the presence of metastatic cancer in the regional L.N. of patients with muscle-invasive bladder cancer at the time of cystectomy with PLND for presumed localized muscle-invasive disease. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ability of a mononuclear-cell gene signature, alone or in combination with pathological staging, to predict any metastatic disease w/i 2 yrs of cystectomy with PLND in pts. with clinical organ-confined muscle-invasive bladder cancer staging. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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URINARY BLADDER, Bladder, Blood sample, Lymph Nodes