Actively Recruiting

Age: 18Years +
All Genders
NCT07464470

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

Led by Blokhin's Russian Cancer Research Center · Updated on 2026-03-12

30

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older included in the GASTROBRAIN study with clinicopathological and treatment data available
  • Histologically confirmed gastric adenocarcinoma, esophageal carcinoma (adenocarcinoma or squamous cell carcinoma), or gastroesophageal junction adenocarcinoma
  • History of neurosurgical removal of brain metastases with available archived tissue
  • Availability of paired formalin-fixed paraffin-embedded tissue samples from primary tumor and matched brain metastasis
Not Eligible

You will not qualify if you...

  • Presence of multiple primary cancers involving other sites besides the stomach, esophagus, or gastroesophageal junction
  • Primary tumor located outside the gastrointestinal tract
  • Histologically confirmed non-epithelial gastrointestinal cancers such as neuroendocrine tumors, sarcoma, gastrointestinal stromal tumor, or lymphoma
  • Brain metastases limited to skull bones or soft tissues without brain parenchymal involvement
  • Tumor cell content less than 70% in microdissected area or poor sample quality affecting molecular testing
  • Missing either the primary tumor or brain metastasis tissue sample from the paired set

AI-Screening

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Trial Site Locations

Total: 1 location

1

Blokhin's Russian Cancer Research Center

Moscow, Russia, 115478

Actively Recruiting

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Research Team

D

David Khalafyan, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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