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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

June 10, 2009
June 14, 2011
June 2009
June 2014   (final data collection date for primary outcome measure)
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 ]
Assess the ability of a mononuclear-cell gene signature to predict the presence of metast 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 ]
Complete list of historical versions of study NCT00918008 on ClinicalTrials.gov Archive Site
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 ]
Assess the ability of a mononuclear-cell gene signature, alone or in combination with pathological staging, to predict any metast disease w/i 2 yrs of cystectomy with PLND in patients with clinical organ-confined muscle-invasive bladder cancer staging. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

single blood sample

Non-Probability Sample

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.

Bladder Cancer
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.
Blood sample
the blood sample only collected prior to surgery
Intervention: Genetic: Blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00918008
09-054
Not Provided
Guido Dalbagni, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • New York Presbyterian Hospital
  • Weill Medical College of Cornell University
Principal Investigator: Guido Dalbagni, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP