Clinical trial · Observational
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
NCT06449989CI-TRIAL-00093485GENCONCOR-1recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF Gene Mutation | — | UNRESOLVED | — |
| Brain Metastases, Adult | — | UNRESOLVED | — |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| HER2 Gene Mutation | — | UNRESOLVED | — |
| MSI | — | UNRESOLVED | — |
| Ras (KRAS or NRAS) Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Concordance rate (%)
- timeFrame
- 1 month
- description
- Concordance rate (%) between mutational status of the brain lesions and their corresponding primary tumor. Calculated as the ratio of concordant cases to total cases.
Secondary outcomes (3)
- measure
- Intracranial progression-free survival (CNS-PFS1)
- timeFrame
- 3 months
- description
- Time from the date of cancer diagnosis to the date of detection of brain metastases.
- measure
- Overall survival (OS)
- timeFrame
- 6 months
- description
- Time from the date of detection of brain metastases to the date of death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.