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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00918008
• Other study ID #: 09-054
• Status: Terminated
• Phase: N/A
• First received: June 10, 2009
• Last updated: March 4, 2015
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York Presbyterian Hospital-Weill Medical College of Cornell University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York Presbyterian Hospital, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan Kettering Cancer Center