HER2-positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma in Russia
A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma
1 other identifier
observational
204
1 country
31
Brief Summary
This study is a multicenter non-interventional observational retrospective study with secondary data collection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedJuly 20, 2025
July 1, 2025
1.2 years
May 29, 2023
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To describe the clinical and demographic profiles of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in the Russian Federation
6 months
Secondary Outcomes (4)
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation
6 months
To describe data on the treatment approach in patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation
6 months
To assess the treatment outcomes of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation
6 months
To characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories
6 months
Eligibility Criteria
300 adult patients with HER2-positive locally advanced/metastatic gastric and/or gastroesophageal junction cancer who are monitored and treated
You may qualify if:
- Patients with locally advanced/metastatic gastric and/or gastroesophageal junction (GEJ) adenocarcinoma, with the diagnosis established between the 1st January 2022 and the 1st January 2023.
- Patients with documented HER2+ status based on IHC score ± ISH status.
- Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status by the reference laboratory.
You may not qualify if:
- Patients receiving trastuzumab deruxtecan currently or in the anamnesis.
- The participation in any randomized controlled trial within period since diagnosis (between the 1st January 2022 and the 1st January 2023) until the timepoint of data collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Arkhangelsk, Russia
Research Site
Barnaul, Russia
Research Site
Belgorod, Russia
Research Site
Chelyabinsk, Russia
Research Site
Chita, Russia
Research Site
Grozny, Russia
Research Site
Irkutsk, Russia
Research Site
Kaluga, Russia
Research Site
Kemerovo, Russia
Research Site
Khabarovsk, Russia
Research Site
Khanty-Mansiysk, Russia
Research Site
Kostroma, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Maykop, Russia
Research Site
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Omsk, Russia
Research Site
Perm, Russia
Research Site
Ryazan, Russia
Research Site
Saint Petersburg, Russia
Research Site
Severodvinsk, Russia
Research Site
Sochi, Russia
Research Site
Surgut, Russia
Research Site
Tomsk, Russia
Research Site
Tver', Russia
Research Site
Ufa, Russia
Research Site
Ulan-Ude, Russia
Research Site
Volgograd, Russia
Research Site
Yaroslavl, Russia
Research Site
Yuzhno-Sakhalinsk, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2023
First Posted
June 7, 2023
Study Start
May 30, 2023
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
July 20, 2025
Record last verified: 2025-07