Recruiting

Urothelial Cancer

Sponsor:

Lahey Clinic

Code:

NCT00872495

Conditions

Urothelial Cancer

Cancer

Bladder Neoplasms

Urinary Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of urothelial cancer of the bladder and kidney. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence

Conditions

Urothelial Cancer

Cancer

Bladder Neoplasms

Urinary Bladder Cancer

Study ID

NCT00872495

Start date

Sep, 2002

Status verified date

Dec, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)
  • Control Group: No known evidence of bladder cancer-one urine sample
  • > than 18 years of age

Exclusion Criteria:

  • < than 18 years of age

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Bladder Cancer Group:

Patients scheduled to have a cystectomy or cystoscopy of their bladder with possible removal or biopsy of bladder tumor or tissue.

Two urine samples collected at the time of the scheduled procedure:

One sample collected through voiding. The other sample collected from atheterized urine in the operating room. Additional urine samples may be collected at each follow up visit over two years. These samples will be obtained via voiding, standard urine sample collection.

2

Control Group: Patients with no known evidence of bladder cancer. One urine sample will be collected through voiding, as with standard urine sample collection at the time of clinic visit.

Primary outcome measure

  • To evaluate the utility of emerging technologies in the detection of bladder tumor cells using non-invasive approaches utilizing voided urine samples. [ Time Frame: Ongoing Lab analysis for study duration: final data completion date ]

Central Contacts and Locations

Central contacts

Kimberly Rieger-Christ, PhD

781-744-2969Kimberly.R.Christ@lahey.org

Linda M. Topjian

781-744-8711Linda.M.Topjian@Lahey.org

Locations

Lahey Clinic, Inc.

Recruiting

Burlington, Massachusetts, United States, 01805

More Information

Sponsor

Lahey Clinic

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Urothelial Cancer
  • Cancer
  • Bladder Neoplasms
  • Urinary Bladder Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lahey Clinic on 2025-12-08.