Colorectal Cancer Metastatic Clinical Trial
— GENCONCOR-1Official title:
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
NCT number | NCT06449989 |
Other study ID # | 115522143966 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2024 |
Est. completion date | April 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Blokhin's Russian Cancer Research Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
Blokhin's Russian Cancer Research Center |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance rate (%) | Concordance rate (%) between mutational status of the brain lesions and their corresponding primary tumor. Calculated as the ratio of concordant cases to total cases. | 1 month | |
Secondary | Intracranial progression-free survival (CNS-PFS1) | Time from the date of cancer diagnosis to the date of detection of brain metastases. | 3 months | |
Secondary | Overall survival (OS) | Time from the date of detection of brain metastases to the date of death. | 6 months | |
Secondary | Intracranial progression-free survival (CNS-PFS2) | Time from the date of neurosurgical resection to the date of intracranial progression (continued growth or distant brain metastases) or death. | 3 months |
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