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

NCT00918008 | Terminated

• 1 other identifier: 09-054
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bladder Cancer

Keywords

URINARY BLADDER; Bladder; Blood sample; Lymph Nodes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Blood sample

the blood sample only collected prior to surgery

Genetic: Blood draw

Interventions

Blood draw GENETIC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• New York Presbyterian Hospital: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

single blood sample

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guido Dalbagni, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (2)