An observational study in Bladder Cancer, Urothelial Carcinoma (UC) and Hematuria, sponsored by Convergent Genomics, Inc.. Recruiting at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Convergent Genomics, Inc. · Observational
This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Convergent Genomics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing evaluation, treatment, or surveillance for urologic tract cancers, including bladder cancer, upper tract urothelial cell carcinoma, or urethral urothelial cell carcinoma, as well as individuals undergoing evaluation for hematuria. Participants are identified and enrolled at participating clinical sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
GROUP 1: Bladder Cancer and/or Upper Tract UCC
GROUP 2: Hematuria Controls
Exclusion Criteria:
GROUP 1: Bladder Cancer and/or Upper Tract UCC
GROUP 2: Hematuria Controls
- Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recurrence Free Survival (RFS)
RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma
Time frame: From enrollment through completion of available clinical follow-up, up to 5 years.
Diagnostic Detection Performance in Hematuria Triage
Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup.
Time frame: From enrollment through completion of diagnostic evaluation, up to 5 years.
Comparison to Alternative Urine Biomarkers
Comparison of the investigational urine biomarker to alternative urine biomarker assays, including cytology and UroVysion FISH, for the detection of urothelial cancer recurrence. Comparison will include lead time, sensitivity, specificity, negative predictive value, and positive predictive value.
Time frame: From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence
A subject with diagnostic lead time will be defined as a subject with a negative cystoscopy and concurrent positive investigational urine biomarker with confirmed urothelial cancer recurrence on study. Lead time will be calculated as the time from the positive urine biomarker result to the date of histopathologic confirmation.
Time frame: From enrollment up to 5 years.
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Plan to share: Yes — Deidentified patient data, inclusive of clinical risk factors, tumor staging and recurrence outcomes.
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Dec 2034, 182 months after the start.
Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's planned 182 months is above that.
Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Convergent Genomics, Inc.