Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade
14. januar 2022 opdateret af: Guilherme Godoy, Baylor College of Medicine
A Prospective Study To Assess Whether A Preoperative Tumor Biopsy Can Improve Upon The Endoscopic Impression Determination Of Stage And Grade In Non-Muscle-Invasive Urothelial Carcinoma Of The Bladder
To assess whether the addition of a bladder tumor biopsy improves the level of agreement between the pretreatment endoscopic impression and the final postoperative pathology determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Non-invasive bladder cancer is challenging to treat because it is a condition characterized by frequent recurrences that lead to numerous invasive procedures for detection and treatment.
The mainstay of therapy for non-muscle invasive bladder cancer, which has remained unchanged for decades, relies on surgical resection (TUR) associated with utilization of intravesical immunotherapy and chemotherapy.
Despite our best efforts, these tumors continue to have suboptimal rates of recurrence and require long-term follow-up with costly and invasive procedures.
The rationale for this study is to show that the preoperative biopsy, taken at the time of the office cystoscopic evaluation, improves pre-TUR staging and grading correlation with the final pathology of the resection.
Indirectly, this will suggest that the routine use of pre-TUR biopsy provides more accurate information for intraoperative decision-making that can ultimately lead to better management of these patients with non-muscle-invasive bladder cancer.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sharon Harrison
- Telefonnummer: 713-798-2240
- E-mail: sharons@bcm.edu
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Baylor College of Medicine
-
Kontakt:
- Guilherme Godoy, MD
- Telefonnummer: 713-798-4001
- E-mail: godoy@bcm.edu
-
Ledende efterforsker:
- Guilherme Godoy, MD
-
-
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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or females, age 21 or older;
- Clinical evidence of urothelial carcinoma of the bladder;
- Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or multiple, at initial occurrence or recurrent with >12 months interval free of disease;
- Surgically eligible for the TUR;
- Patient or authorized proxy needs to have signed the informed consent form.
Exclusion Criteria:
- History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher);
- Patients with sessile appearing bladder tumors, which may be T2 or higher stage;
- Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract;
- Concurrent use of anticoagulation medication or chronic use of NSAIDs, including aspirin (other than cardio protective doses of 80mg daily) that has not been appropriately interrupted before the office cystoscopic evaluation;
- Patient deemed medically or psychologically unfit for the surgical procedure;
- Subject has received any investigational medication within 30 days prior to the registration or is scheduled to receive an investigational drug during the course of the study;
Women Exclusion
- Pregnant or lactating women.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Bladder tumor biopsy
All subjects will undergo a bladder tumor biopsy followed by transurethral resection.
|
Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.
Tidsramme: 3 years
|
Assessment of grade, which is the main endpoint will be dichotomous defining lesions between low versus high grade.
Stage classification of non-muscle-invasive papillary lesions is also dichotomous between Ta and T1 lesions.
CIS can be annotated, but since these are flat, diffuse and non "resectable" in the bladder, they are not part of our main analysis, endpoints, or sample size calculations.
The only exception is when the presence of CIS is used to determine grade (high-grade lesion).
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Guillherme Godoy, MD, Baylor College of Medicine
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)
1. april 2018
Primær færdiggørelse (Forventet)
1. maj 2023
Studieafslutning (Forventet)
1. december 2023
Datoer for studieregistrering
Først indsendt
8. december 2016
Først indsendt, der opfyldte QC-kriterier
13. december 2016
Først opslået (Skøn)
14. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-40414
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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