Sammenligning av molekylær-genetisk konkordans av primærtumor og hjernemetastaser av kolorektal kreft (GENCONCOR-1)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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 (%).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: David Halafyan, MD
- Telefonnummer: +7(930)928-00-72
- E-post: daveupnow@gmail.com
Studiesteder
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Moscow
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Moscow, Moscow, Russland, 115478
- Rekruttering
- Blokhin's Russian Cancer Research Center
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Ta kontakt med:
- David Halafyan, MD
- Telefonnummer: +7(930)928-00-72
- E-post: daveupnow@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients with metastatic colorectal cancer (CRC) and brain metastases (BM) will be analyzed according to sex, age, functional status (ECOG 0-1 or 2-3), number of BM (solitary or ≥ 2), clinical manifestations of BM (symptomatic or asymptomatic), extracranial lesions at the time of diagnosis BM (present or absent), course of brain metastases (synchronous with the primary tumor or metachronous), side of the location of the primary tumor (left-sided or right-sided CRC), location of intracranial lesions (supratentorial or subtentorial), number of previous lines of drug therapy.
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Missing one sample from a pair of tumor samples.
- Low quality or lack of tumor material for molecular genetic research.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Concordance rate (%)
Tidsramme: 1 month
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intracranial progression-free survival (CNS-PFS1)
Tidsramme: 3 months
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Time from the date of cancer diagnosis to the date of detection of brain metastases. |
3 months
|
|
Overall survival (OS)
Tidsramme: 6 months
|
Time from the date of detection of brain metastases to the date of death. |
6 months
|
|
Intracranial progression-free survival (CNS-PFS2)
Tidsramme: 3 months
|
Time from the date of neurosurgical resection to the date of intracranial progression (continued growth or distant brain metastases) or death. |
3 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Alexey Tryakin, MD, professor, Blokhin's Russian Cancer Research Center
- Studiestol: Ali Bekyashev, MD, professor, Blokhin's Russian Cancer Research Center
- Studiestol: Anna Stroganova, MD, Blokhin's Russian Cancer Research Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Neoplasmer i hjernen
- Genomkomponenter
- Genom
- Genetiske strukturer
- Genetiske fenomener
- Gener
- Proto-onkogener
- Onkogener
- Gener, neoplasi
- Genes, mos
Andre studie-ID-numre
- 115522143966
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data that underline the results reported in article, after deidentification (text, tables, figures, and appendices)
IPD-delingstidsramme
From the moment of publication of the results and indefinitely
Tilgangskriterier for IPD-deling
For individual participant data meta-analysis. Data will be available indefinitely in the appendix of the published article
Legemiddel- og utstyrsinformasjon, studiedokumenter
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