Identification of p53 gene mutations in bladder cancers and urine samples.
D Sidransky, A Von Eschenbach, Y C Tsai...
https://pubmed.ncbi.nlm.nih.gov/2024123Actively Recruiting
Led by Lahey Clinic · Updated on 2025-12-08
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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)
Total: 1 location
1
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Actively Recruiting
K
Kimberly Rieger-Christ, PhD
L
Linda M. Topjian
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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