Идёт набор NCT06449989

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

— Наблюдательное Colorectal Cancer Metastatic Brain Metastases, Adult Ras (KRAS or NRAS) Gene Mutation BRAF Gene Mutation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI.
Кому может быть актуально: Состояния в реестре: Colorectal Cancer Metastatic, Brain Metastases, Adult, Ras (KRAS or NRAS) Gene Mutation, BRAF Gene Mutation. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Россия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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 (%).

Вмешательства

Диагностический тест Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI
For molecular genetic research, archival formalin-fixed and paraffin-embedded tumor blocks will be used. Research method - HRM-PCR sequencing to determine mutation status of KRAS, NRAS and BRAF (RotorGene 6000, ABI Prism 3500) and fragmentation analysis to determine MSI (ABI Prism 3500) Subject to study: mutations in the KRAS, NRAS, BRAF genes, as well as MSI status and HER2neu expression (± amplification) Somatic mutations in the RAS family genes are planned to be studied in exons 2 (codons 12

Первичные конечные точки

Concordance rate (%) [Срок оценки: 1 month]

Вторичные конечные точки (3)

Intracranial progression-free survival (CNS-PFS1) [Срок оценки: 3 months]
Overall survival (OS) [Срок оценки: 6 months]
Intracranial progression-free survival (CNS-PFS2) [Срок оценки: 3 months]

Критерии участия

Критерии включения

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.
Presence of paired tumor samples (both primary tumor and intracranial material).