Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449989
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Brief Title:
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
Sponsor:
Blokhins Russian Cancer Research Center
Organization:
Blokhins Russian Cancer Research Center
Study Overview
Official Title:
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENCONCOR-1
Brief Summary:
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 027 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 NN 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
In NN 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None