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

NCT07464470 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-12

No results posted yet for this study

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)

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Alexey Tryakin, MD, PhD, professor · Blokhin's Russian Cancer Research Center

  • Ali Bekyashev, MD, PhD, professor · Blokhin's Russian Cancer Research Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-10-01
Completion
2028-10-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464470 on ClinicalTrials.gov