CClinicalTrials.gg
CompletedNCT05892926Updated Jul 20, 2025

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

An observational study in Adenocarcinoma, sponsored by AstraZeneca. Completed at 31 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
204
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Adenocarcinoma

Browse trials for

03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 204 is above the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
204 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

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

    Time frame: 6 months

07

Study locations

31 sites
  • Research Site
    Arkhangelsk, Russia
  • Research Site
    Barnaul, Russia
  • Research Site
    Belgorod, Russia
  • Research Site
    Chelyabinsk, Russia
  • Research Site
    Chita, Russia
  • Research Site
    Grozny, Russia
  • Research Site
    Irkutsk, Russia
  • Research Site
    Kaluga, Russia
  • Research Site
    Kemerovo, Russia
  • Research Site
    Khabarovsk, Russia
  • Research Site
    Khanty-Mansiysk, Russia
  • Research Site
    Kostroma, Russia
  • Research Site
    Krasnodar, Russia
  • Research Site
    Krasnoyarsk, Russia
  • Research Site
    Maykop, Russia
  • Research Site
    Moscow, Russia
  • Research Site
    Nizhny Novgorod, Russia
  • Research Site
    Omsk, Russia
  • Research Site
    Perm, Russia
  • Research Site
    Ryazan, Russia
  • Research Site
    Saint Petersburg, Russia
  • Research Site
    Severodvinsk, Russia
  • Research Site
    Sochi, Russia
  • Research Site
    Surgut, Russia
  • Research Site
    Tomsk, Russia
  • Research Site
    Tver', Russia
  • Research Site
    Ufa, Russia
  • Research Site
    Ulan-Ude, Russia
  • Research Site
    Volgograd, Russia
  • Research Site
    Yaroslavl, Russia
  • Research Site
    Yuzhno-Sakhalinsk, Russia
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05892926
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 7, 2023
Start date
May 30, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Jul 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion