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BRIEF TITLE: Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer

Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer


  • Org Study ID: 14-006
  • Secondary ID:
  • NCT ID: NCT02969109
  • NCT Alias:
  • Sponsor: Genomic Health®, Inc. - Industry
  • Source: Genomic Health®, Inc.

Brief Summary

A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 2015 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: The recurrence status based on the pathology results

Primary Outcome 1 - Time Frame: 1 year

Primary Outcome 2 - Measure: The Genomic Health bladder cancer assay results.

Primary Outcome 2 - Time Frame: 1 year

Condition:

  • Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma
of the bladder scheduled to undergo surveillance cystoscopy.

Exclusion Criteria:

- Patients younger than 18 years

- Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell
carcinoma of the bladder

- Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2
or greater)

- Patients who are unable or unwilling to give informed consent
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Keith Gran

Phone: 650-569-2042

Email: kgran@genomichealth.com

Location

Facility Status Contact
Institute for Prostate and Urologic Cancers - University of Minnesota
Minneapolis, Minnesota 55455
United States
Recruiting