Molecular comparison of primary gastroesophageal cancers and their brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective translational analysis of paired FFPE samples from primary tumors and surgically resected brain metastases drawn from the international GASTROBRAIN cohort. Pathology testing will determine HER2 status (IHC ± FISH), MSI status (IHC ± PCR), PD-L1 combined positive score (CPS), and CLDN18.2 expression by IHC in both sites. The main objective is to compare molecular-genetic concordance between the matched primary and brain metastatic lesions. Findings will be correlated with available clinicopathological and treatment data to contextualize discordance and potential treatment implications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Synchronous or metachronous multiple primary malignancies involving sites other than the stomach, esophagus, or gastroesophageal junction.
2. Primary tumor located outside the gastrointestinal tract.
3. Histologically confirmed non-epithelial gastrointestinal malignancy (e.g., neuroendocrine tumors, sarcoma, gastrointestinal stromal tumor, lymphoma).
4. Intact brain parenchyma (e.g., metastases confined to skull bones or soft tissues of the head without brain parenchymal involvement).
5. 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
6. Missing one sample from a paired set (either primary tumor or brain metastasis unavailable).

Where it's running

• Blokhin's Russian Cancer Research Center
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: David Khalafyan, MD
• Email: daveupnow@gmail.com
• Phone: +7(930)928-00-72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.