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RECRUITING
NCT07464470

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers

Sponsor: Blokhin's Russian Cancer Research Center

View on ClinicalTrials.gov

Summary

GENCONCOR-2 is a translational research aimed to compare the molecular profile of primary tumors and their matched brain metastases in gastroesophageal cancers, including cancer of the esophagus, gastroesophageal junction, and stomach. The study is based on the previously established international GASTROBRAIN cohort (ClinicalTrials.gov ID: NCT07448493), which provides comprehensive clinicopathological and treatment data for over 230 patients. It will be conducted by retrospective analysis of paired samples of histological material (primary tumor and corresponding brain metastasis) with determination of HER2 expression status (IHC ± FISH), MSI status (IHC ± PCR), PD-L1 combined positive score (CPS), and CLDN18.2 expression status (IHC)

Official title: Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers (GENCONCOR-2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2028-10-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

HER2 Testing

Assessment of HER2 status by immunohistochemistry (IHC) using SP3 antibody clone (DAKO) on Ventana GX platform with OptiView detection system. Cases with IHC 2+ will undergo confirmatory in situ hybridization (FISH, CISH, or SISH).

DIAGNOSTIC_TEST

MSI Testing

Determination of microsatellite instability status by immunohistochemistry (IHC) for mismatch repair proteins (MLH1, MSH2, MSH6, PMS2) ± PCR-based analysis using five mononucleotide repeat markers (BAT25, BAT26, NR21, NR24, NR27).

DIAGNOSTIC_TEST

PD-L1 Testing

Assessment of PD-L1 expression by immunohistochemistry (IHC) using DAKO 22C3 antibody clone on Dako Link48 platform with EnVision Flex detection system. Results reported as Combined Positive Score (CPS), defined as number of PD-L1-stained cells divided by total viable tumor cells, multiplied by 100.

DIAGNOSTIC_TEST

CLDN18.2 Testing

Assessment of CLDN18.2 expression by immunohistochemistry (IHC) using VENTANA CLDN18 (43-14A) assay on Ventana platform. Positive expression defined as moderate-to-strong (2+/3+) complete, basolateral, or lateral membranous staining in ≥ 75% of viable tumor cells.

Locations (1)

Blokhin's Russian Cancer Research Center

Moscow, Russia