Trial Title:
HER2-positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma in Russia
NCT ID:
NCT05892926
Condition:
Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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
Criteria for eligibility:
Study pop:
300 adult patients with HER2-positive locally advanced/metastatic gastric and/or
gastroesophageal junction cancer who are monitored and treated
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Balashikha
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Belgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chita
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Grozny
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Grozny
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irkutsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Istra
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Izhevsk
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaluga
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kazan
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Khabarovsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khanty-Mansiysk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khimki
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kirov
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Klin
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kolomna
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kostroma
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnodar
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Maykop
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nalchik
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nizhny Novgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Noyabrsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orenburg
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Perm
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Perm
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Plievo
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Ryazan
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Samara
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saratov
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Severodvinsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sochi
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Surgut
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Syktyvkar
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tver
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulan-Ude
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulyanovsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Volgograd
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Voronezh
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yekaterinburg
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yuzhno-Sakhalinsk
Country:
Russian Federation
Status:
Recruiting
Start date:
May 30, 2023
Completion date:
July 1, 2024
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892926
