Multicentric Prospective T1 Urinary Bladder Cancer Registry

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05792033

Studienbeginn:
Juni 2021

Letztes Update:
04.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
University of Turin, Italy

Kontakt

David D'Andrea, MD
Kontakt:
Phone: +434040026150
E-Mail: david.dandrea@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
David D'Andrea, MD
E-Mail: david.dandrea@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Synopsis Rationale Patients with T1 urinary bladder cancer (UBC) are at high risk for

recurrence and progression. However, the prognosis is dependent on several concomitant

factors. First and foremost, an accurate diagnosis is imperative for an appropriate disease

management. Due to conventional transurethral resection technique, resulting in fragmentation

and cauterization of the tissue, the pathological review is often difficult and may result in

under or over-staging. A central pathology review of EORTC trial data found only a 43%

concordance for T1 tumours compared with staging by a local pathologist. Moreover, risk

factors such as concomitant carcinoma in situ (CIS), variant histology (VH) and

lymphovascular invasion (LVI) have been associated with even poorer prognosis in patients

with T1 UBC. However, there is consistent heterogeneity in reporting these features across

studies.

There is an unmet need for a clean prospective dataset on T1 UBC to allow an accurate risk

stratification in order to aid clinical decision making.

Study endpoints The primary objective of the study is to prospectively collect data on

patients with primary diagnosis of T1 NMIBC in order

- to investigate the therapy failure rates in patients with primary diagnosis of T1

bladder cancer

- to investigate the association of clinico-pathologic features such as LVI, VH and CIS,

tumor size and number of tumors with pathologic outcomes.

- to analyze the accuracy of the local pathologist assessment on the evaluation of

pathology features such as tumor stage and grade, substaging according to the

microscopic and extensive invasion, LVI, VH and CIS.

- to investigate the inter-observer variability among different local pathologist

comparing these observations with a central pathology revision performed by expert

genitourinary pathologist.

- to develop a clinically applicable risk stratification tool which may guide physicians

during patient counselling and decision-making regrading adjuvant therapies or early

cystectomy

Methods Patients with primary diagnosis of UBC and scheduled for transurethral resection of

bladder at international urology departments will be prospectively recruited. Patients with

confirmed diagnosis of T1 UBC will be included in the study All selected patients will be

asked to sign a written informed consent and any locally required privacy act document

authorization prior to TURB. Furthermore, all patients will be required to provide consent

for central pathology revision.

Patients will receive adjuvant treatments (i.e. intravesical therapy or early cystectomy)

according to guidelines and clinical standards. All data regarding these treatments will be

prospectively collected during the study period or patient death.

The clinical data of patients included in the study will be prospectively collected at each

center and saved within an electronic case report form (eCRF) using the Castor platform

(Castor www.castoredc.com). After combining the data sets from the different centers, reports

will be generated for each variable identifying missing or inconsistent data. Incongruities

will be solved before freezing the final database. Protected health information (PHI) will be

unavailable to investigators at other sites. Follow-up chart abstractions will occur at

6-month intervals until the patient is deceased, lost to follow-up, or the study is

terminated.

Pathologic specimens will be scanned and uploaded to the eCRF to allow a central pathologic

revision.

Rationale for patient number Recurrence rates for T1 bladder cancer are estimated to be up to

50% [4]. We plan to include 700 patients in the study. This would allow to detect a 50%

failure rate with 4% on either side of the 95% Confidence Interval (proportion 0,50 with

95%CI 0.46-0.54).

Future prospects, dissemination and impact A manuscript will be written and submitted for

publication on a scientific journal. Any formal presentation or publication of data collected

from this trial will be considered as a joint publication by the investigators.

Studies originating from this registry could potentially change the risk stratification and,

therefore, the management of patients with T1 UBC.

Ein-/Ausschlusskriterien

Inclusion criteria

Subjects must meet all the following inclusion criteria to participate in this study:

- Pathologically confirmed diagnosis of primary T1 bladder cancer

- Diagnosis of primary T1 bladder cancer is confirmed at 2nd look TURB

- Imaging examinations shows no lymph node metastasis or distant metastasis

- Patients who agree to surgery, and will be effected to the standard postoperative

management and follow-up treatment in accordance to current guidelines

- In case of persistent T1 bladder cancer at 2nd look TURB, patient can be included only

if detrusor muscle is present in the pathologic specimen

Exclusion criteria

- Previous bladder cancer

- Upstaging to MIBC at 2nd look TURB

- Contraindications to surgery (i.e. bladder fibrosis)

- Poor performance status making a surgical intervention too risky

- Life expectancy of less than one year

- Patient refused to participate

- Pregnancy

- Concomitant or history of upper urinary tract urothelial cancer

Studien-Rationale

Primary outcome:

1. Therapy failure (Time Frame - 2021 to 2028):
Proportion of patients failing intravesical BCG Therapy and undergo radical cystectomy and the proportion of patients treated with upfront radical cystectomy

Geprüfte Regime

Prospective registry:
Prospective registry of patients with primary diagnosis of T1 urinary bladder cancer

Quelle: ClinicalTrials.gov

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