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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Oceanside, California, Forenede Stater, 92056
        • Aktiv, ikke rekrutterende
        • Urology San Diego
      • San Diego, California, Forenede Stater, 92123
        • Aktiv, ikke rekrutterende
        • Genesis Research, LLC
      • San Jose, California, Forenede Stater, 95124
        • Aktiv, ikke rekrutterende
        • Urology Associates of Silicon Valley
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60657
        • Aktiv, ikke rekrutterende
        • UroPartners, LLC
      • Grayslake, Illinois, Forenede Stater, 60030
        • Aktiv, ikke rekrutterende
        • UroPartners, LLC
      • Mount Prospect, Illinois, Forenede Stater, 60056
        • Aktiv, ikke rekrutterende
        • UroPartners, LLC
      • Niles, Illinois, Forenede Stater, 60068
        • Aktiv, ikke rekrutterende
        • UroPartners, LLC
      • Wheaton, Illinois, Forenede Stater, 60187
        • Aktiv, ikke rekrutterende
        • UroPartners, LLC
    • Maryland
      • Hanover, Maryland, Forenede Stater, 21076
        • Aktiv, ikke rekrutterende
        • Chesapeake Urology Research Associates
    • Michigan
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Aktiv, ikke rekrutterende
        • Comprehensive Urology
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Aktiv, ikke rekrutterende
        • Sheldon J. Freedman MD LTD
    • New York
      • New York, New York, Forenede Stater, 10016
        • Aktiv, ikke rekrutterende
        • Manhattan Medical Research Practice
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Aktiv, ikke rekrutterende
        • The Urology Group
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37209
        • Aktiv, ikke rekrutterende
        • Urology Associates, P.C.
    • Texas
      • Austin, Texas, Forenede Stater, 78681
        • Aktiv, ikke rekrutterende
        • Urology Austin - Round Rock
      • Austin, Texas, Forenede Stater, 78705
        • Aktiv, ikke rekrutterende
        • Midtown Urology Associates
      • Austin, Texas, Forenede Stater, 78759
        • Aktiv, ikke rekrutterende
        • Urology Austin - Medical Park Tower
      • Dallas, Texas, Forenede Stater, 75390
      • San Antonio, Texas, Forenede Stater, 78229
        • Aktiv, ikke rekrutterende
        • Urology San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • Aktiv, ikke rekrutterende
        • UT Health San Antonio
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23462
        • Aktiv, ikke rekrutterende
        • Urology of Virginia
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Aktiv, ikke rekrutterende
        • Ashford Med Center
      • San Juan, Puerto Rico, 00935
        • Aktiv, ikke rekrutterende
        • PanOncology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
Hematuria Controls

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrence Free Survival (RFS)
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison to Alternative Urine Biomarkers
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Convergent Genomics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2019

Primær færdiggørelse (Anslået)

1. december 2034

Studieafslutning (Anslået)

1. december 2034

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CG-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified patient data, inclusive of clinical risk factors, tumor staging and recurrence outcomes.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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