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

Recruiting now

Conditions studied: Gastric Cancer, Esophageal Cancer, Brain Metastases

In brief

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)

Key facts

Study ID

NCT07464470

Run by

Blokhin's Russian Cancer Research Center

People needed

30

Starts

2026-04-01

Expected to finish

2028-10-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 years or older included in the GASTROBRAIN study with available clinicopathological and treatment data.
• Histologically confirmed gastric adenocarcinoma, esophageal carcinoma (adenocarcinoma or squamous cell carcinoma), or gastroesophageal junction adenocarcinoma.
• History of neurosurgical resection of brain metastases with available archival tissue material, and histological confirmation of metastatic lesion originating from gastroesophageal cancer.
• Availability of paired FFPE tissue samples from primary tumor and matched brain metastasis.

You may not qualify if…

• Synchronous or metachronous multiple primary malignancies involving sites other than the stomach, esophagus, or gastroesophageal junction.
• Primary tumor located outside the gastrointestinal tract.
• Histologically confirmed non-epithelial gastrointestinal malignancy (e.g., neuroendocrine tumors, sarcoma, gastrointestinal stromal tumor, lymphoma).
• Intact brain parenchyma (e.g., metastases confined to skull bones or soft tissues of the head without brain parenchymal involvement).
• Insufficient tumor material or poor sample quality for molecular analysis, defined as:
• Tumor cell content < 70% in the area of microdissection, or
• Significant nucleic acid degradation compromising molecular testing
• Missing one sample from a paired set (either primary tumor or brain metastasis unavailable).

Where it is running

• Blokhin's Russian Cancer Research Center — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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