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

AstraZeneca1 site in 1 country204 target enrollmentMay 30, 2023

ConditionsAdenocarcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adenocarcinoma
Sponsor: AstraZeneca
Enrollment: 204
Locations: 1
Primary Endpoint: To describe the clinical and demographic profiles of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in the Russian Federation
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

May 30, 2023

End Date

July 31, 2024

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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
•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

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 characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories(6 months)
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)