Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID00872495

Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney

Led by Lahey Clinic · Updated on 2025-12-08

500

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether analyzing DNA and protein materials found in urine can help detect urothelial cancer of the bladder and kidney. The study aims to understand if these analyses can predict how the cancer behaves in terms of remission and recurrence. This observational study includes patients with tumors and control patients without bladder cancer to evaluate the accuracy of new non-invasive testing methods compared to current standard procedures. Participants include two groups: one with bladder cancer patients scheduled for procedures like cystectomy, cystoscopy, or nephroureterectomy, and a control group without known bladder cancer. Urine samples will be collected through voiding and catheterization during scheduled procedures and follow-up visits over two years. The study will assess DNA mutations and protein biomarkers in urine, comparing these findings with standard cytology and cystoscopy results. Participants will provide urine samples at scheduled clinical visits and procedures, with samples processed for DNA and protein analysis. Researchers will use various molecular techniques to detect mutations and protein markers linked to bladder cancer presence and progression. The primary outcome is to evaluate the usefulness of these non-invasive urine tests in detecting bladder tumor cells. The study will continue collecting and analyzing samples until November 2028, with participants followed over two years for sample collection and monitoring.

CONDITIONS

Brief Title

Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled to have a nephroureterectomy, cystectomy, or cystoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)
  • Control group participants with no known evidence of bladder cancer
  • Adults aged 18 years and older
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 years

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of scheduled procedure

Participants scheduled for cystectomy, cystoscopy, or nephroureterectomy provide urine samples collected via voiding and catheterization during the procedure to assess bladder tumor presence using non-invasive assays.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants in the bladder cancer group provide additional urine samples via voiding during follow-up visits to monitor tumor presence or progression over time.

Regular clinic visits over 2 years for urine sample collection

Single Sample Collection for Control Group

Duration - Single visit

Control participants with no known bladder cancer provide one urine sample via voiding at a scheduled clinic visit to evaluate background presence of biomarkers.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Lahey Clinic, Inc.

Burlington, Massachusetts, United States, 01805

Actively Recruiting

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Research Team

K

Kimberly Rieger-Christ, PhD

L

Linda M. Topjian

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection.

Kimberly M Rieger-Christ, Arthur Mourtzinos, Peter J Lee...

https://pubmed.ncbi.nlm.nih.gov/12910517