Clinical trial · Observational
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney
NCT00872495CI-TRIAL-00098602recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Neoplasms | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- 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.
- label
- 2
- description
- 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 outcomes (1)
- measure
- To evaluate the utility of emerging technologies in the detection of bladder tumor cells using non-invasive approaches utilizing voided urine samples.
- timeFrame
- Ongoing Lab analysis for study duration: final data completion date
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDSidransky D, Von Eschenbach A, Tsai YC, Jones P, Summerhayes I, Marshall F, Paul M, Green P, Hamilton SR, Frost P, et al. Identification of p53 gene mutations in bladder cancers and urine samples. Science. 1991 May 3;252(5006):706-9. doi: 10.1126/science.2024123. PMID 2024123
- BACKGROUNDLevesque P, Ramchurren N, Saini K, Joyce A, Libertino J, Summerhayes IC. Screening of human bladder tumors and urine sediments for the presence of H-ras mutations. Int J Cancer. 1993 Nov 11;55(5):785-90. doi: 10.1002/ijc.2910550516. PMID 7902340
- BACKGROUNDFitzgerald JM, Ramchurren N, Rieger K, Levesque P, Silverman M, Libertino JA, Summerhayes IC. Identification of H-ras mutations in urine sediments complements cytology in the detection of bladder tumors. J Natl Cancer Inst. 1995 Jan 18;87(2):129-33. doi: 10.1093/jnci/87.2.129. PMID 7707384
- BACKGROUNDRieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. doi: 10.1002/cncr.11536. PMID 12910517