Cancer Clinical Trial
Official title:
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney
NCT number | NCT00872495 |
Other study ID # | 2002-061 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2002 |
Est. completion date | November 2025 |
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
Status | Recruiting |
Enrollment | 500 |
Est. completion date | November 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lahey Clinic, Inc. | Burlington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Lahey Clinic |
United States,
Fitzgerald 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. — View Citation
Levesque 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. — View Citation
Rieger-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. Erratum In: Cancer. 2003 Nov 1;98(9):2000. — View Citation
Sidransky 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the utility of emerging technologies in the detection of bladder tumor cells using non-invasive approaches utilizing voided urine samples. | Ongoing Lab analysis for study duration: final data completion date |
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