Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
|ClinicalTrials.gov Identifier: NCT01802905|
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : February 5, 2015
|Condition or disease||Intervention/treatment|
|Advanced Incurable Cancers||Genetic: in depth genomic sequencing|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies|
|Study Start Date :||June 2012|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
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.
- Frequency of actioanble genomic abnormalites detected that modify treatment [ Time Frame: up to 24 months ]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 ]What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802905
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Janessa J. Laskin, MD FRCPC||British Columbia Cancer Agency|
|Principal Investigator:||Marco Marra, PhD FRSC||Genome Sciences Centre, BC Cancer Agency|