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The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-Intensified Arm | Experimental | Less-frequent cystoscopy surveillance |
|
| Standard Surveillance Arm | No Intervention | Regular follow-ups and standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroAmp Test (Convergent Genomics, Inc.) | Diagnostic Test | Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cystoscopies | The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure. | From enrollment to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease | From enrollment to 24 months |
| Recurrence-free survival | We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups |
| Measure | Description | Time Frame |
|---|---|---|
| Interim Analysis | After 50% enrollment, the rate of conversion from low-risk on the utDNA test to high risk will be evaluated at 3 months. If this rate exceeds 50%, the study will be terminated for futility. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Topjian | Contact | 7817448420 | Linda.M.Topjian@lahey.org | |
| Colette Osborne | Contact | Colette.A.Osborne@lahey.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew B Clements, MD, MS | Lahey Hospital & Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital and Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Clinical Trials in Progress: Bladder Cancer: Monday, April 28, 9-11 am. Journal of Urology. https://doi.org/10.1097/01.JU.0001110440.53375.7d | ||
| 37439796 | Background | Salari K, Sundi D, Lee JJ, Wu S, Wu CL, DiFiore G, Yan QR, Pienkny A, Lee CK, Oberlin D, Barme G, Piser J, Kahn R, Collins E, Phillips KG, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, Evans-Holm ME, MacBride AR, Fischer DS, Haddadzadeh IJ, Mazzarella BC, Gray JW, Koppie TM, Bicocca VT, Levin TG, Lotan Y, Feldman AS. Development and Multicenter Case-Control Validation of Urinary Comprehensive Genomic Profiling for Urothelial Carcinoma Diagnosis, Surveillance, and Risk-Prediction. Clin Cancer Res. 2023 Sep 15;29(18):3668-3680. doi: 10.1158/1078-0432.CCR-23-0570. | |
| 36233691 |
| Label | URL |
|---|---|
| Patient-oriented presentation on the study | View source |
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Considering whether to involve other sites in the trial
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| From enrollment to 24 months |
| Patient-reported outcomes | The National Comprehensive Cancer Network Distress thermometer and the European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Non-Muscle Invasive Bladder Cancer (NMIBC-24) Module will be collected and compared between study arms | From enrollment to 24 months |
| Background |
| Bicocca VT, Phillips KG, Fischer DS, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, MacBride AR, Jensen BW, Mazzarella BC, Koppie T, Korkola JE, Gray JW, Levin TG. Urinary Comprehensive Genomic Profiling Correlates Urothelial Carcinoma Mutations with Clinical Risk and Efficacy of Intervention. J Clin Med. 2022 Sep 30;11(19):5827. doi: 10.3390/jcm11195827. |
| D001749 |
| Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |