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


N/A
18 Years
N/A
Not Enrolling
Male
Bladder Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Guido Dalbagni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-054

NCT ID:

NCT00918008

Start Date:

June 2009

Completion Date:

June 2014

Related Keywords:

  • Bladder Cancer
  • URINARY BLADDER
  • Bladder
  • Blood sample
  • Lymph Nodes
  • Urinary Bladder Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
New York Presbyterian Hospital-Weill Medical College of Cornell University New York, New York  10065