About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

T1 tumor

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants

are grouped into 3 trial groups

Group A: Patients with NMIBC

Group B: Patients with MIBC

Group C: Patients with mBC

Trial outcomes

Primary outcomes

1

Proportion of patients receiving any intravesical treatment among patients with high-risk NMIBC

Proportion of patients receiving any intravesical treatment among patients with high-risk Non-muscle invasive bladder cancer (ongoing and anamnestic);

Time frame

24 months

2

Proportion of patients receiving intravesical chemotherapy among patients with high-risk NMIBC

Proportion of patients receiving intravesical chemotherapy among patients with high-risk ongoing and anamnestic Non-muscle invasive bladder cancer (overall and by each treatment regimen);

Time frame

24 months

3

Proportion of patients receiving intravesical BCG treatment among patients with high-risk NMIBC

Proportion of patients receiving intravesical Bacillus Calmette-Guérin treatment among patients with high-risk ongoing and anamnestic Non-muscle-invasive bladder cancer (overall and by each treatment regimen: induction/ induction + maintenance);

Time frame

24 months

4

Proportion of patients receiving any intravesical treatment among patients with non-high-risk NMIBC

Proportion of patients receiving any intravesical treatment among patients with non-high-risk Non-muscle-invasive bladder cancer (anamnestic);

Time frame

24 months

Secondary outcomes

1

Prevalence of IHC-defined HER2-positive status among patients with high-risk NMIBC

Prevalence of immunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumor tissue samples) among patients with high-risk Non-muscle-invasive bladder cancer;

Time frame

24 months

2

Prevalence of IHC-defined HER2-positive status among patients with MIBC

Prevalence of mmunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with Muscle-invasive bladder cancer;

Time frame

24 months

3

Prevalence of IHC-defined HER2-positive status among patients with mBC;

Prevalence of mmunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with mBC;

Time frame

24 months

4

Concordance of immunohistochemically-defined HER2-positive status among 3 patient cohorts

Concordance of immunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with Non-muscle-invasive bladder cancer, muscle-invasive bladder cancer and metastatic bladder cancer in primary tumor samples and metastasis if both available;

Time frame

24 months

Locations20

Select a site below to view it on the map.

TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts