RecruitingNCT06449989

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

Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

Brain Metastases, Adult Colorectal Cancer Metastatic Ras (Kras or Nras) Gene Mutation BRAF Gene Mutation HER2 Gene Mutation MSI

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares the genetic makeup of primary colorectal tumors to their brain metastases — cancer that has spread to the brain — to understand whether the two sites share the same mutations. This could help guide personalized treatment decisions. **You may be eligible if...** - You are 18 or older - You have histologically confirmed colorectal cancer that has spread to the brain - You have undergone or are planned for neurosurgical removal of the brain metastasis - Both a primary tumor sample and a brain metastasis sample are available **You may NOT be eligible if...** - Only one of the two tumor samples is available - The available tumor tissue is of insufficient quality for genetic testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTumor 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).