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Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer

NCT06449989 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-08-12

No results posted yet for this study

Summary

GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.

Conditions

  • Colorectal Cancer Metastatic
  • Brain Metastases, Adult
  • Ras (KRAS or NRAS) Gene Mutation
  • BRAF Gene Mutation
  • HER2 Gene Mutation
  • MSI

Interventions

DIAGNOSTIC_TEST

Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI

For molecular genetic research, archival formalin-fixed and paraffin-embedded tumor blocks will be used. Research method - HRM-PCR sequencing to determine mutation status of KRAS, NRAS and BRAF (RotorGene 6000, ABI Prism 3500) and fragmentation analysis to determine MSI (ABI Prism 3500) Subject to study: mutations in the KRAS, NRAS, BRAF genes, as well as MSI status and HER2neu expression (± amplification) Somatic mutations in the RAS family genes are planned to be studied in exons 2 (codons 12 and 13), exon 3 (codon 61) and exon 4 (codon 146). In the case of the BRAF gene - exon 15 (codons 597-601). Determination of microsatellite instability is planned using five markers: BAT25, BAT26, NR21, NR24, NR27, associated with structural and functional disorders of the DNA unpaired base repair system. Assessment of HER2 gene status is planned by immunohistochemical (IHC) screening of HER2neu expression. IHC-screening of HER2-status will be performed using an antibody clone 4B5 (Ventana).

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

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

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

  • Anna Stroganova, MD · Blokhin's Russian Cancer Research Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Russia

Study Locations

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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 NCT06449989 on ClinicalTrials.gov