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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Bladder Cancer

Treatments: Genetic: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT00918008

09-054

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Blood sample

Description:

the blood sample only collected prior to surgery

Treatment:

Genetic: Blood draw