NCT07464470 Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers
| NCT ID | NCT07464470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Blokhin's Russian Cancer Research Center |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-04-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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).
Contact & Investigator
Alexey Tryakin, MD, PhD, professor
STUDY CHAIR
Blokhin's Russian Cancer Research Center
Frequently Asked Questions
Who can join the NCT07464470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07464470 currently recruiting?
Yes, NCT07464470 is actively recruiting participants. Contact the research team at daveupnow@gmail.com for enrollment information.
Where is the NCT07464470 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07464470 clinical trial?
NCT07464470 is sponsored by Blokhin's Russian Cancer Research Center. The principal investigator is Alexey Tryakin, MD, PhD, professor at Blokhin's Russian Cancer Research Center. The trial plans to enroll 30 participants.
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