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

July 17, 2025 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Research Site
      • Barnaul, Russian Federation
        • Research Site
      • Belgorod, Russian Federation
        • Research Site
      • Chelyabinsk, Russian Federation
        • Research Site
      • Chita, Russian Federation
        • Research Site
      • Grozny, Russian Federation
        • Research Site
      • Irkutsk, Russian Federation
        • Research Site
      • Kaluga, Russian Federation
        • Research Site
      • Kemerovo, Russian Federation
        • Research Site
      • Khabarovsk, Russian Federation
        • Research Site
      • Khanty-Mansiysk, Russian Federation
        • Research Site
      • Kostroma, Russian Federation
        • Research Site
      • Krasnodar, Russian Federation
        • Research Site
      • Krasnoyarsk, Russian Federation
        • Research Site
      • Maykop, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhny Novgorod, Russian Federation
        • Research Site
      • Omsk, Russian Federation
        • Research Site
      • Perm, Russian Federation
        • Research Site
      • Ryazan, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Severodvinsk, Russian Federation
        • Research Site
      • Sochi, Russian Federation
        • Research Site
      • Surgut, Russian Federation
        • Research Site
      • Tomsk, Russian Federation
        • Research Site
      • Tver, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
      • Ulan-Ude, Russian Federation
        • Research Site
      • Volgograd, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
      • Yuzhno-Sakhalinsk, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

300 adult patients with HER2-positive locally advanced/metastatic gastric and/or gastroesophageal junction cancer who are monitored and treated

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
6 months
To characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D133HR00028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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