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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Men and women over 18 years of age. 2. Histologically confirmed cancer of the colon or rectum. 3. Histologically confirmed metastatic lesion of the brain. 4. Neurosurgical resection for brain metastases of colorectal cancer. 5. Presence of paired tumor samples (both primary tumor and intracranial material).

Exclusion Criteria:

1. Missing one sample from a pair of tumor samples. 2. Low quality or lack of tumor material for molecular genetic research.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06449989
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Blokhin's Russian Cancer Research Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexey Tryakin, MD, professorAli Bekyashev, MD, professorAnna Stroganova, MD
Principal Investigator Affiliation	Blokhin's Russian Cancer Research CenterBlokhin's Russian Cancer Research CenterBlokhin's Russian Cancer Research Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Colorectal Cancer Metastatic, Brain Metastases, Adult, Ras (KRAS or NRAS) Gene Mutation, BRAF Gene Mutation, HER2 Gene Mutation, MSI

Additional Details

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 (%).

Contact a Trial Team

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International Sites

Blokhin's Russian Cancer Research Center, Moscow, Russian Federation

Status

Recruiting

Address

Blokhin's Russian Cancer Research Center

Moscow, , 115478

Site Contact

David Halafyan, MD

[email protected]

+7(930)928-00-72

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