An International Randomized Study to Compare SPIES Versus WLI
27. juli 2021 opdateret af: Clinical Research Office of the Endourological Society
The SPIES Non-Muscle-Invasive Bladder Cancer Study - A Multicenter Randomized Controlled Study; A Multicenter International Randomized Controlled Study to Compare the Outcome Using the Storz Professional Image Enhancement System (SPIES) Versus White Light Imaging (WLI) During TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).
This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared.
Subjects in the experimental arm (Arm A) will undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive treatment with WLI assisted TURB only.
Baseline characteristics will be recorded, as well as short and long-term follow up.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared.
Randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where CIS is scored as flat lesion).
Patients randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB, whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB.
WLI is chosen as control, since it is considered the gold standard for detecting bladder tumors.
Short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period.
Perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of SPIES.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
700
Fase
- Ikke anvendelig
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Has signed informed consent
- Is scheduled for treatment of a primary or recurrent NMIBC
- Is aged 18 years or older
- Has or has had no tumors in the upper urinary tract
- Has had no previous irradiation of the pelvis
Exclusion Criteria:
- Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
- Conditions associated with a risk of poor protocol compliance
- Has had instillation therapy in the six months prior to the screening visit
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: A
SPIES+WLI assisted TURB
|
|
|
Aktiv komparator: B
WLI assisted TURB
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B)
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.
Tidsramme: 3 years
|
3 years
|
|
2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score.
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Jean de la Rosette, Clinical Research Office of the Endourological Society
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. april 2015
Primær færdiggørelse (Faktiske)
1. april 2020
Studieafslutning (Faktiske)
1. juli 2021
Datoer for studieregistrering
Først indsendt
26. september 2014
Først indsendt, der opfyldte QC-kriterier
26. september 2014
Først opslået (Skøn)
30. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NL50451.018.14
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med SPIES+WLI assisted TURB
-
Mansoura UniversityUkendtCystoskopi | Urothelial carcinom i blæren | Blære neoplasma | TURBTEgypten