TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

Official title

A Multicentre Observational Study on Treatment Approaches and HER2 Positive Status Prevalence in Different Stages of Bladder Cancer and PD-L1-positive Status in Metastatic Bladder Cancer in Russian Federation

Overview

A multicentre observational study on treatment approaches and HER2 positive status prevalence in different stages of bladder cancer and PD-L1-positive status in metastatic bladder cancer in Russian Federation

Detailed description

This is an observational study entailing primary and secondary data collection. As an observational, this study does not imply any intervention into a routine clinical practice, including choice of treatment modality or additional diagnostic methods. Epidemiologic methods and descriptive analysis will be used for data collection and evaluation of all endpoints and measurements of interest.

It will be a multicentre study. Planned number of study sites is about 30 oncological centres performing specialised treatment and follow-up of patients with urothelial bladder cancer in different regions of Russia. Planned study population consists of approximately 600 adult patients with urothelial bladder cancer. Patients who were diagnosed with urothelial bladder cancer and satisfy the additional eligibility criteria as assessed by the investigator will be invited to participate during routine clinical visit. Only patients who will give their written informed consent will be included. Consecutive patients included in the study will form three study cohorts of equal size (around 200 participants each) according to the stages of urothelial bladder cancer at the time of study inclusion: high-risk NMIBC, MIBC, and mBC.

The investigator will enter medical data of the enrolled patients into the electronic case report form (eCRF) from the source medical documentation. No follow-up is planned, the study will consist of only one visit carried out according to routine clinical practice, where patient's demographic and clinical characteristics as well as medical history and used treatment approaches will be recorded, and formalin-fixed paraffin-embedded (FFPE) tumour tissue samples collected as part of routine clinical practice will be shipped to the central laboratory.

The overall expected duration of the study enrollment is about 18 months or until 600 patients will be included in the study, and all required data (including results of IHC testing in central laboratory) will be collected, whichever occurs first.

Primary outcome measures

• Proportion of patients receiving any intravesical treatment among patients with high-risk NMIBC [Time frame: 24 months]
• Proportion of patients receiving intravesical chemotherapy among patients with high-risk NMIBC [Time frame: 24 months]
• Proportion of patients receiving intravesical BCG treatment among patients with high-risk NMIBC [Time frame: 24 months]
• Proportion of patients receiving any intravesical treatment among patients with non-high-risk NMIBC [Time frame: 24 months]
• Proportion of patients receiving intravesical chemotherapy among patients with non-high-risk anamnestic NMIBC [Time frame: 24 months]
• Proportion of patients receiving intravesical BCG treatment among patients with non high-risk anamnestic NMIBC [Time frame: 24 months]
• Proportion of patients without intravesical NMIBC treatment [Time frame: 24 months]
• Number of relapses in high risk NMIBC patients (ongoing and anamnestic) overall and by each treatment regimen [Time frame: 24 months]
• Number of relapses in non-high risk NMIBC patients overall and by each treatment regimen, intravesical BCG [Time frame: 24 months]
• Time to first relapse of NMIBC [Time frame: 24 months]

Secondary outcome measures (5)

• Prevalence of IHC-defined HER2-positive status among patients with high-risk NMIBC [Time frame: 24 months]
• Prevalence of IHC-defined HER2-positive status among patients with MIBC [Time frame: 24 months]
• Prevalence of IHC-defined HER2-positive status among patients with mBC; [Time frame: 24 months]
• Concordance of immunohistochemically-defined HER2-positive status among 3 patient cohorts [Time frame: 24 months]
• Prevalence of PD-L1 positive status among patients with mBC [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years;
• Signed ICF, including consent for FFPE tumor tissue sample testing;
• Confirmed diagnosis of urothelial bladder cancer at NMIBC, MIBC, or mBC stage at study entry;
• For patients with NMIBC: 1. TURBT performed at least 1 month but not more than 12 months prior to study entry; 2. Presence of ≥1 high-risk feature:

• T1 tumor
• High grade/G3 tumor
• CIS (carcinoma in situ)
• Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point);
• For patients with MIBC: Сystectomy performed at least 2 months but not more than 12 months prior to study entry;
• For patients with mBC: mBC diagnosed during 12 months prior to study entry;
• Availability of medical history data;
• Availability of FFPE tumour tissue sample obtained during biopsy and/or surgery.

Exclusion criteria

• Participation in any interventional trial since the urothelial bladder cancer diagnosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Russia · 22 centers

• Research Site — Arkhangelsk
• Research Site — Barnaul
• Research Site — Chelyabinsk
• Research Site — Krasnodar
• Research Site — Krasnoyarsk
• Research Site — Makhachkala
• Research Site — Moscow
• Research Site — Moscow
• … and 14 more centers

Identifiers

NCT: NCT07038928 · D133HR00057

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗