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NCT05892926 Clinical Trial

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

Adenocarcinoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05892926
Other study ID # D133HR00028
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2023
Est. completion date July 1, 2024

Study information
Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Research Site Arkhangelsk
Russian Federation Research Site Balashikha
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 Grozny
Russian Federation Research Site Irkutsk
Russian Federation Research Site Istra
Russian Federation Research Site Izhevsk
Russian Federation Research Site Kaluga
Russian Federation Research Site Kazan
Russian Federation Research Site Kemerovo
Russian Federation Research Site Khabarovsk
Russian Federation Research Site Khanty-Mansiysk
Russian Federation Research Site Khimki
Russian Federation Research Site Kirov
Russian Federation Research Site Klin
Russian Federation Research Site Kolomna
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 Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Nalchik
Russian Federation Research Site Nizhny Novgorod
Russian Federation Research Site Novokuznetsk
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Noyabrsk
Russian Federation Research Site Omsk
Russian Federation Research Site Orenburg
Russian Federation Research Site Perm
Russian Federation Research Site Perm
Russian Federation Research Site Plievo
Russian Federation Research Site Rostov-on-Don
Russian Federation Research Site Ryazan
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Samara
Russian Federation Research Site Saratov
Russian Federation Research Site Severodvinsk
Russian Federation Research Site Sochi
Russian Federation Research Site Surgut
Russian Federation Research Site Syktyvkar
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 Ulyanovsk
Russian Federation Research Site Vladivostok
Russian Federation Research Site Volgograd
Russian Federation Research Site Voronezh
Russian Federation Research Site Yaroslavl
Russian Federation Research Site Yekaterinburg
Russian Federation Research Site Yuzhno-Sakhalinsk

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary To characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories 6 months
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