Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer

Cepheid

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: Xpert Bladder Cancer Monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT03125460

170 (Other Identifier)

Details and patient eligibility

About

The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.

Enrollment: 424 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subject is ≥ 40 years of age
• Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
• Subject is considered disease positive within 12 months (365 days) of enrollment.
• At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
• Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
• Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
• Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.

Exclusion

• Subject has been previously enrolled into the study.
• Urine specimen to be used for study purposes is from the first morning void.
• Subject has had an excision procedure within six weeks (42 days) of enrollment.
• The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.

Trial design

424 participants in 2 patient groups

Initial Enrollment

Description:

Initial enrollment of patients with history of bladder cancer

Treatment:

Device: Xpert Bladder Cancer Monitor

Longitudinal Cohort

Description:

Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient

Treatment:

Device: Xpert Bladder Cancer Monitor