Clinical trial NCT00918008: A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
Official title: A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Cancer
Keywords: URINARY BLADDER
Bladder
Blood sample
Lymph Nodes
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Weill Medical College of Cornell University
First posted: 2009-06-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Guido Dalbagni, MD
role: PRINCIPAL_INVESTIGATOR
References: