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

March 26, 2024 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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

200

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 Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Recruiting
        • Research Site
      • Balashikha, Russian Federation
        • Withdrawn
        • Research Site
      • Belgorod, Russian Federation
        • Recruiting
        • Research Site
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Research Site
      • Grozny, Russian Federation
        • Withdrawn
        • Research Site
      • Grozny, Russian Federation
        • Recruiting
        • Research Site
      • Irkutsk, Russian Federation
        • Recruiting
        • Research Site
      • Istra, Russian Federation
        • Withdrawn
        • Research Site
      • Kaluga, Russian Federation
        • Recruiting
        • Research Site
      • Kazan, Russian Federation
        • Not yet recruiting
        • Research Site
      • Kemerovo, Russian Federation
        • Withdrawn
        • Research Site
      • Khabarovsk, Russian Federation
        • Recruiting
        • Research Site
      • Khanty-Mansiysk, Russian Federation
        • Recruiting
        • Research Site
      • Kirov, Russian Federation
        • Withdrawn
        • Research Site
      • Kostroma, Russian Federation
        • Recruiting
        • Research Site
      • Krasnodar, Russian Federation
        • Recruiting
        • Research Site
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Research Site
      • Maykop, Russian Federation
        • Recruiting
        • Research Site
      • Moscow, Russian Federation
        • Recruiting
        • Research Site
      • Moscow, Russian Federation
        • Not yet recruiting
        • Research Site
      • Moscow, Russian Federation
        • Withdrawn
        • Research Site
      • Nalchik, Russian Federation
        • Not yet recruiting
        • Research Site
      • Nizhny Novgorod, Russian Federation
        • Recruiting
        • Research Site
      • Novokuznetsk, Russian Federation
        • Withdrawn
        • Research Site
      • Novosibirsk, Russian Federation
        • Not yet recruiting
        • Research Site
      • Novosibirsk, Russian Federation
        • Withdrawn
        • Research Site
      • Noyabrsk, Russian Federation
        • Not yet recruiting
        • Research Site
      • Omsk, Russian Federation
        • Recruiting
        • Research Site
      • Orenburg, Russian Federation
        • Not yet recruiting
        • Research Site
      • Perm, Russian Federation
        • Not yet recruiting
        • Research Site
      • Perm, Russian Federation
        • Withdrawn
        • Research Site
      • Plievo, Russian Federation
        • Not yet recruiting
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Withdrawn
        • Research Site
      • Ryazan, Russian Federation
        • Recruiting
        • Research Site
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Research Site
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Research Site
      • Saint Petersburg, Russian Federation
        • Withdrawn
        • Research Site
      • Samara, Russian Federation
        • Withdrawn
        • Research Site
      • Saratov, Russian Federation
        • Withdrawn
        • Research Site
      • Severodvinsk, Russian Federation
        • Not yet recruiting
        • Research Site
      • Sochi, Russian Federation
        • Recruiting
        • Research Site
      • Surgut, Russian Federation
        • Recruiting
        • Research Site
      • Syktyvkar, Russian Federation
        • Withdrawn
        • Research Site
      • Tomsk, Russian Federation
        • Recruiting
        • Research Site
      • Tver, Russian Federation
        • Recruiting
        • Research Site
      • Ufa, Russian Federation
        • Recruiting
        • Research Site
      • Ulan-Ude, Russian Federation
        • Recruiting
        • Research Site
      • Ulyanovsk, Russian Federation
        • Withdrawn
        • Research Site
      • Vladivostok, Russian Federation
        • Not yet recruiting
        • Research Site
      • Volgograd, Russian Federation
        • Recruiting
        • Research Site
      • Voronezh, Russian Federation
        • Withdrawn
        • Research Site
      • Yaroslavl, Russian Federation
        • Recruiting
        • Research Site
      • Yekaterinburg, Russian Federation
        • Withdrawn
        • Research Site
      • Yuzhno-Sakhalinsk, Russian Federation
        • Not yet recruiting
        • 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

Ages Eligible for Study

  • Child
  • 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

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

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

AstraZeneca

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)

May 30, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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