Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
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ClinicalTrials.gov Identifier: NCT00872495 |
Recruitment Status
:
Recruiting
First Posted
: March 31, 2009
Last Update Posted
: January 11, 2018
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Condition or disease |
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Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer |

Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney |
Study Start Date : | September 2002 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | November 2025 |

Group/Cohort |
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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.
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- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872495
Contact: Kimberly Rieger-Christ, PhD | 781-744-2969 | Kimberly.R.Christ@lahey.org | |
Contact: Linda M. Topjian | 781-744-8711 | Linda.M.Topjian@Lahey.org |
United States, Massachusetts | |
Lahey Clinic, Inc. | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Sub-Investigator: Arthur Mourtzinos, M.D. | |
Sub-Investigator: Andrea Sorcini, M.D. | |
Sub-Investigator: Leonard Zinman, M.D. | |
Sub-Investigator: Ali Moinzadeh, M.D. | |
Sub-Investigator: David Canes, M.D. |
Principal Investigator: | Kimberly Rieger-Christ, PhD | Lahey Clinic, Inc. |
Publications:
Responsible Party: | Linda Topjian, study coordinator, Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00872495 History of Changes |
Other Study ID Numbers: |
2002-061 |
First Posted: | March 31, 2009 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
Keywords provided by Linda Topjian, Lahey Clinic:
Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer |
Additional relevant MeSH terms:
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |