NCT07673016 Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
| NCT ID | NCT07673016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Convergent Genomics, Inc. |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2019-10-15 |
| Primary Completion | 2034-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2019-10-15 with a primary completion date of 2034-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: GROUP 1: Bladder Cancer and/or Upper Tract UCC * Male or female ≥ 18 years of age who are scheduled for transurethral resection of bladder tumor (TURBT) and/or biopsy of urinary tract or * Patients on surveillance who are negative for recurrence or tumor at the time of study enrollment but have had previous urothelial cell carcinoma (UCC) or * Patients with muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC) scheduled for NAC and/or subsequent radical cystectomy (RC) * Able to provide consent prior to diagnostic TURBT, nephroureterectomy, or administration of NAC and/or RC * Able to provide at least 20cc urine. If patient cannot void sufficient volume of urine, urologist can pull urine from the bladder via catheter or cystoscope. Urine should not be collected immediately after resection * Participation in other bladder cancer studies is allowed. Experimental therapy must be documented in the case report forms GROUP 2: Hematuria Controls * Male or female ≥ 18 years of age presenting with gross or microscopic hematuria as defined by standard of care * No evidence of and/or history of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection * Able to provide consent * Able to provide at least 20cc urine * Participation in other studies is allowed. Experimental therapy must be documented in the case report forms Exclusion Criteria: GROUP 1: Bladder Cancer and/or Upper Tract UCC * Clinical, symptomatic urinary tract infection at time of initial urine collection * Unable to provide adequate urine sample 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
Frequently Asked Questions
Who can join the NCT07673016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07673016 currently recruiting?
Yes, NCT07673016 is actively recruiting participants. Visit ClinicalTrials.gov or contact Convergent Genomics, Inc. to inquire about joining.
Where is the NCT07673016 trial being conducted?
This trial is being conducted at Oceanside, United States, San Diego, United States, San Jose, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT07673016 clinical trial?
NCT07673016 is sponsored by Convergent Genomics, Inc.. The trial plans to enroll 2,500 participants.
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