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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 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

2500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Convergent Genomics, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. oktober 2019

Primær fullføring (Antatt)

1. desember 2034

Studiet fullført (Antatt)

1. desember 2034

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

24. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)