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

Completed

• Conditions: Adenocarcinoma

• Registration Number: NCT05892926
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-05-29
• Study Start: 2023-05-30
• Study First Posted: 2023-06-07
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yuzhno-Sakhalinsk, Russian Federation