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

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Research Site
RECRUITING
Arkhangelsk
Research Site
RECRUITING
Barnaul
Research Site
RECRUITING
Krasnoyarsk
Research Site
NOT_YET_RECRUITING
Moscow
Research Site
RECRUITING
Moscow
Research Site
NOT_YET_RECRUITING
Nizhny Novgorod
Research Site
NOT_YET_RECRUITING
Novosibirsk
Research Site
NOT_YET_RECRUITING
Obninsk
Research Site
NOT_YET_RECRUITING
Omsk
Research Site
RECRUITING
Saint Petersburg
Research Site
NOT_YET_RECRUITING
Tomsk
Research Site
NOT_YET_RECRUITING
Ufa
Research Site
RECRUITING
Ufa
Research Site
RECRUITING
Yekaterinburg
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Treatments
Patients with NMIBC
Non-muscle-invasive bladder cancer
Patients with MIBC
Muscle-invasive bladder cancer
Patients with mBC
Metastatic bladder cancer
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov