Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer (NCT06310759)
Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies With High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer (UROSCOUT-1)
🩺 Plain-English Summary (8th-Grade Level)
Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.
Who can join: Review the eligibility criteria below.
Location: Jesse Brown Department Of Veterans Affairs Medical Center — Chicago, Illinois
Age range: 18 Years to 100 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Jesse Brown Department Of Veterans Affairs Medical Center — Chicago, Illinois
- Vancouver Prostate Centre — Vancouver, British Columbia
- Helsinki University Hospital — Helsinki,
- Satasairaala Hospital — Pori,
- Seinäjoki Central Hospital — Seinäjoki,
- Tampere University Hospital and Tampere University — Tampere,
- Turku University Hospital — Turku,
- Kindai University Hospital — Osaka,
📞 Contact the Study Coordinator
Phone: 03311611
Email: jussi.nikkola@fimnet.fi
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urothelial Carcinoma
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- Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma — Philadelphia, Pennsylvania
- A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma — Houston, Texas
- A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder — Bloomington, Indiana
- Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma — Oklahoma City, Oklahoma
- Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC — Tampa, Florida
Explore by condition: All Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.