Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Metastatic, Brain Metastases, Adult, Ras (KRAS or NRAS) Gene Mutation, BRAF Gene Mutation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Brain metastases (BM) from colorectal cancer (CRC) are a rare event reported in less than 3% of patients with CRC (the reported incidence ranges from 0.27 to 3%). This course is associated with a poor prognosis. Treatment of these patients remains challenging. Nevertheless, given the rarity of the event, at this time not enough is known about molecular biology of BM from colorectal cancer and its concordance with matched primary tumors.
In N.N. Blokhin National Medical Research Center of Oncology over 26 years (1998-2024) identified 108 patients with BM from CRC. Of this number, 72 patients had a history of neurosurgical resection of BM. In turn, for 32 patients access to a pair of tumor samples: from the primary tumor and from intracranial metastases. Tumor samples will be tested for mutation status of genes KRAS, NRAS, BRAF, HER2 and MSI. Analysis was limited to this pool of genes because of their clinical relevance and potential prognostic information. The molecular profile of the BM will be compared with the corresponding primary tumor with calculation of concordance rate (%).
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
Primary outcome measures
- Concordance rate (%) [Time frame: 1 month]
Secondary outcome measures (3)
- Intracranial progression-free survival (CNS-PFS1) [Time frame: 3 months]
- Overall survival (OS) [Time frame: 6 months]
- Intracranial progression-free survival (CNS-PFS2) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Men and women over 18 years of age.
- Histologically confirmed cancer of the colon or rectum.
- Histologically confirmed metastatic lesion of the brain.
- Neurosurgical resection for brain metastases of colorectal cancer.
- Presence of paired tumor samples (both primary tumor and intracranial material).
Exclusion criteria
- Missing one sample from a pair of tumor samples.
- Low quality or lack of tumor material for molecular genetic research.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Blokhin's Russian Cancer Research Center — Moscow
Identifiers
NCT: NCT06449989 · 115522143966