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Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer (INSITE)

24 juni 2026 uppdaterad av: Convergent Genomics, Inc.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

2500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- California
  - Oceanside, California, Förenta staterna, 92056
    - Aktiv, inte rekryterande
    - Urology San Diego
  - San Diego, California, Förenta staterna, 92123
    - Aktiv, inte rekryterande
    - Genesis Research, LLC
  - San Jose, California, Förenta staterna, 95124
    - Aktiv, inte rekryterande
    - Urology Associates of Silicon Valley
- Illinois
  - Chicago, Illinois, Förenta staterna, 60657
    - Aktiv, inte rekryterande
    - UroPartners, LLC
  - Grayslake, Illinois, Förenta staterna, 60030
    - Aktiv, inte rekryterande
    - UroPartners, LLC
  - Mount Prospect, Illinois, Förenta staterna, 60056
    - Aktiv, inte rekryterande
    - UroPartners, LLC
  - Niles, Illinois, Förenta staterna, 60068
    - Aktiv, inte rekryterande
    - UroPartners, LLC
  - Wheaton, Illinois, Förenta staterna, 60187
    - Aktiv, inte rekryterande
    - UroPartners, LLC
- Maryland
  - Hanover, Maryland, Förenta staterna, 21076
    - Aktiv, inte rekryterande
    - Chesapeake Urology Research Associates
- Michigan
  - Royal Oak, Michigan, Förenta staterna, 48073
    - Aktiv, inte rekryterande
    - Comprehensive Urology
- Nevada
  - Las Vegas, Nevada, Förenta staterna, 89144
    - Aktiv, inte rekryterande
    - Sheldon J. Freedman MD LTD
- New York
  - New York, New York, Förenta staterna, 10016
    - Aktiv, inte rekryterande
    - Manhattan Medical Research Practice
- Ohio
  - Cincinnati, Ohio, Förenta staterna, 45212
    - Aktiv, inte rekryterande
    - The Urology Group
- Tennessee
  - Nashville, Tennessee, Förenta staterna, 37209
    - Aktiv, inte rekryterande
    - Urology Associates, P.C.
- Texas
  - Austin, Texas, Förenta staterna, 78681
    - Aktiv, inte rekryterande
    - Urology Austin - Round Rock
  - Austin, Texas, Förenta staterna, 78705
    - Aktiv, inte rekryterande
    - Midtown Urology Associates
  - Austin, Texas, Förenta staterna, 78759
    - Aktiv, inte rekryterande
    - Urology Austin - Medical Park Tower
  - Dallas, Texas, Förenta staterna, 75390
    - Rekrytering
    - UT Southwestern Medical Center
    - Kontakt:
      
      Perla Lopez
      
      Telefonnummer: 214-645-8787
      
      E-post: Perla.Lopez@utsouthwestern.edu
  - San Antonio, Texas, Förenta staterna, 78229
    - Aktiv, inte rekryterande
    - Urology San Antonio
  - San Antonio, Texas, Förenta staterna, 78229
    - Aktiv, inte rekryterande
    - UT Health San Antonio
- Virginia
  - Virginia Beach, Virginia, Förenta staterna, 23462
    - Aktiv, inte rekryterande
    - Urology of Virginia
Puerto Rico
- - San Juan, Puerto Rico, 00907
    - Aktiv, inte rekryterande
    - Ashford Med Center
  - San Juan, Puerto Rico, 00935
    - Aktiv, inte rekryterande
    - PanOncology

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
Hematuria Controls

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Recurrence Free Survival (RFS) Tidsram: From enrollment through completion of available clinical follow-up, up to 5 years.	RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma	From enrollment through completion of available clinical follow-up, up to 5 years.
Diagnostic Detection Performance in Hematuria Triage Tidsram: From enrollment through completion of diagnostic evaluation, up to 5 years.	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.	From enrollment through completion of diagnostic evaluation, up to 5 years.

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Comparison to Alternative Urine Biomarkers Tidsram: From enrollment up to 5 years.	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.	From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence Tidsram: From enrollment up to 5 years.	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.	From enrollment up to 5 years.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Convergent Genomics, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 oktober 2019

Primärt slutförande (Beräknad)

1 december 2034

Avslutad studie (Beräknad)

1 december 2034

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

24 juni 2026

Första postat (Faktisk)

29 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)