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Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies

Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01802905
Enrollment
100
Registered
2013-03-04
Start date
2012-06-30
Completion date
2015-02-28
Last updated
2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Incurable Cancers

Keywords

neoplasm, metastatic cancer, cancer genome, genomic analysis, adults

Brief summary

Most systemic therapies are chosen on the basis of large randomized clinical trials; however, tumour heterogeneity means that cancers with similar histological features may have substantially different underlying biological drivers. The investigators propose that applying personal genomic information prospectively obtained in a clinically realistic timeframe to assist in chemotherapy decision-making could result in more effective and efficient cancer treatment. This study will investigate this approach in a cross section of advanced cancers to examine timeliness, deliverability, rate of actionable targets identified, and our ability to expand this approach into a larger clinical trial setting.

Detailed description

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.

Interventions

GENETICin depth genomic sequencing

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.

Sponsors

BC Cancer Foundation
CollaboratorOTHER
British Columbia Cancer Agency
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Subjects must have histologically or cytologically confirmed diagnosis of cancer 2. This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage). 3. 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. 4. ECOG PS 0 or 1. 5. Age \> 18 years of age. 6. Subject consent must be obtained according to the BCCA requirements. 7. Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.

Exclusion criteria

1. Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA. 2. Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of actioanble genomic abnormalites detected that modify treatmentup to 24 monthsWhat is the frequency of actionable results in this varied tumour population ?

Secondary

MeasureTime frameDescription
What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this testup to 24 monthsWhat is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026