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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2011

Interventions

  • Genetic: Blood draw
    • 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.

Arms, Groups and Cohorts

  • Blood sample
    • the blood sample only collected prior to surgery

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 2 years

Secondary Measures

  • 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.
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Collaborator
    • New York Presbyterian Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guido Dalbagni, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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