- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01802905
Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
It is clear that carcinogenesis is an immensely complex process and that even within a histologic cancer subtype - such as adenocarcinoma of the lung or breast - there is significant heterogeneity in cancer behaviour and response to therapy. Recognizing genetic mutations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents.
Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment. With many recognized mutations personalized evaluation of the genetic signature encoded in DNA and RNA may enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada
- BC Cancer Agency
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects must have histologically or cytologically confirmed diagnosis of cancer
- This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage).
- Subjects must agree to provide archival tissue and agree to undergo a study specific biopsy and blood test for genetic analysis. All subjects would have a biopsy and blood samples at progression if it could be done safely.
- ECOG PS 0 or 1.
- Age > 18 years of age.
- Subject consent must be obtained according to the BCCA requirements.
- Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.
Exclusion Criteria:
- Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA.
- Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Sequenced patients
Patients enrolled on the study who have successful sequencing of their cancers will be closely monitored for: what chemotherapy agents are next used, what response and toxicity do they have, is there any early sign of response detected on PET-CT, overall did the genomic information change treatment decision-making.
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Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of actioanble genomic abnormalites detected that modify treatment
Tidsramme: up to 24 months
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What is the frequency of "actionable" results in this varied tumour population ?
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up to 24 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test
Tidsramme: up to 24 months
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What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
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up to 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Janessa J. Laskin, MD FRCPC, British Columbia Cancer Agency
- Hovedetterforsker: Marco Marra, PhD FRSC, Genome Sciences Centre, BC Cancer Agency
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Peixoto RD; Li Y; Pleasance E; Yip S; et al. A case of the utilization of genomic information in the management of metastatic colorectal cancer. J Clin Oncol 30: 2012 (suppl 34; abstr 444)
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BCCA POG 01
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