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

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood draw	the blood sample only collected prior to surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Locations (2): Memorial Sloan Kettering Cancer Center
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New York, New York, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
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New York, New York, United States

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