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

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 Overview

• Status: Terminated
• Conditions: Bladder Cancer
• Intervention / Treatment: Genetic: Blood draw

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital-Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, and from the Department of Surgery, Urology Service at Memorial Sloan-Kettering Cancer Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood sample; the blood sample only collected prior to surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University; New York Presbyterian Hospital
• Investigators: Principal Investigator: Guido Dalbagni, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Bladder; Lymph Nodes; URINARY BLADDER; Blood sample
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 09-054