Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies|
- Frequency of actioanble genomic abnormalites detected that modify treatment [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]What is the frequency of "actionable" results in this varied tumour population ?
- What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Genetic: in 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802905
|Contact: Janessa J. Laskin, MD FRCPCemail@example.com|
|Contact: Robyn Roscoe, MScfirstname.lastname@example.org|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Robyn Roscoe, MSc email@example.com|
|Principal Investigator: Janessa J. Laskin, MD FRCPC|
|Sub-Investigator: Karen A. Gelmon, MD FRCPC|
|Sub-Investigator: Howard Lim, MD FRCPC|
|Sub-Investigator: Daniel Renouf, MD FRCPC|
|Sub-Investigator: Anna Tinker, MD FRCPC|
|Principal Investigator:||Janessa J. Laskin, MD FRCPC||British Columbia Cancer Agency|
|Principal Investigator:||Marco Marra, PhD FRSC||Genome Sciences Centre, BC Cancer Agency|