HER2-positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma in Russia

AstraZeneca204 enrolled

Overview

This study is a multicenter non-interventional observational retrospective study with secondary data collection

It will be multicenter study. Planned number of study sites is about 50 oncological centers specialized on anticancer chemotherapy in various regions of Russia. A multi-center collaborative effort will help to describe characteristics of patients with HER2-positive gastric and/or GEJ adenocarcinoma in different regions in the most comprehensive way and to capture more patients into database, not only limited to a single institution

Study Type

OBSERVATIONAL

Enrollment

204

Conditions

Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Age ≥ 18 years at the time of inclusion. * Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted. Exclusion Criteria: * 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

Locations (31)

Research Site

Arkhangelsk, Russia

Outcomes

Primary Outcomes

To describe the clinical and demographic profiles of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in the Russian Federation

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 6 months

To characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories

Time frame: 6 months

Data from ClinicalTrials.gov

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