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

This study has been terminated.
Sponsor:
Collaborators:
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00918008
First received: June 10, 2009
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Bladder Cancer
 Genetic: Blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

single blood sample


Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918008

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Weill Medical College of Cornell University
Investigators
Principal Investigator: Guido Dalbagni, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Guido Dalbagni, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00918008     History of Changes
Other Study ID Numbers: 09-054
Study First Received: June 10, 2009
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
URINARY BLADDER
Bladder
Blood sample
Lymph Nodes

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013