Resultater af højrisiko ikke-muskelinvasiv blærekræft behandlet med blålysresektion
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Objectives are as follows:
Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.
Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Armine Smith, MD
- Telefonnummer: 2026605561
- E-mail: asmit165@jhmi.edu
Undersøgelse Kontakt Backup
- Navn: Domani Rodriguez
- Telefonnummer: 2026605561
- E-mail: drodri59@jh.edu
Studiesteder
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20016
- Rekruttering
- Sibley Memorial Hospital
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins University School of Medicine
-
Kontakt:
- Rana Harb
- Telefonnummer: 410-502-5500
- E-mail: rharb1@jhmi.edu
-
Kontakt:
- Faizah Karim
- E-mail: fkarim4@jh.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing TURBT for radiographic or cystoscopic positive tumor
- 18+ years old
- Upper tract evaluated using standard of care throughout duration of the study
- Induction intravesical therapy initiated within four weeks of TURBT
Exclusion Criteria:
- Variant histology consisting of less than 50% urothelial carcinoma
- History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
- Prior history of pelvic radiation
- Active urinary tract infection (UTI)
- Patients who are noncompliant with the study protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Blue light Cystoscopy
Patients with bladder tumors will undergo BLC TURBT |
Blue light cystoscopy uses hexyl aminolevulinate (HAL, branded in the United States as Cysview), a prodrug which accumulates in the bladder tumors and improves the tumor's visualization.
Andre navne:
Cystoscopy procedure
Andre navne:
|
|
Aktiv komparator: White light Cystoscopy
Patients with bladder tumors will undergo WLC TURBT |
Cystoscopy procedure
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Residual disease burden
Tidsramme: Up to 24 months
|
The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals. |
Up to 24 months
|
|
Minimal residual disease burden
Tidsramme: Up to 24 months
|
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals. |
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-free survival
Tidsramme: 24 months
|
Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause. |
24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Armine Smith, MD, Sibley Memorial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Urologiske neoplasmer
- Urinblæresygdomme
- Urinblære neoplasmer
- Terapeutik
- Lægemiddelterapi
- Lægemiddelforsyningssystemer
- hexyl-5-aminolevulinat
Andre undersøgelses-id-numre
- IRB00442199
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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