Actively Recruiting
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
Led by Blokhin's Russian Cancer Research Center · Updated on 2025-08-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the molecular genetic similarity between primary tumors and brain metastases in patients with colorectal cancer. This observational study focuses on patients who have developed brain metastases, a rare and serious complication occurring in less than 3% of colorectal cancer cases. The study aims to better understand the genetic profiles of these tumors by analyzing specific gene mutations and their concordance between original and metastatic sites. The study involves molecular genetic testing of archival tumor samples collected from neurosurgical resections. Researchers will analyze mutations in KRAS, NRAS, BRAF, HER2 genes, and microsatellite instability (MSI) using specialized sequencing and immunohistochemical methods. This testing compares paired samples from both the primary colorectal tumor and its brain metastases to calculate how closely their genetic profiles match. Participants' tumor samples will be examined for mutations and gene expressions using advanced laboratory techniques. The main outcome measured is the concordance rate of genetic mutations between the two tumor sites within one month. Secondary outcomes include monitoring intracranial progression-free survival and overall survival at intervals up to six months. The study involves no active treatment but detailed genetic and clinical follow-up over time to improve understanding of metastatic colorectal cancer biology.
CONDITIONS
Brief Title
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Availability of paired tumor samples from both primary tumor and brain metastases
You will not qualify if you...
- Missing one sample from a pair of tumor samples
- Low quality or lack of tumor material for molecular genetic research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants' tumor samples from the primary tumor and brain metastases are tested for mutation status of KRAS, NRAS, BRAF, HER2, and MSI using molecular genetic methods.
1 visit for sample collection
Duration - Up to 6 months
Participants are observed for intracranial progression-free survival and overall survival following molecular analysis.
Periodic follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Blokhin's Russian Cancer Research Center
Moscow, Moscow, Russia, 115478
Actively Recruiting
Research Team
D
David Halafyan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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