An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:
- Past published information
- Clinical experience and judgement
- Immunohistochemistry for specific targets (e.g., ER)
- Standard sequencing (e.g., for K-Ras) and other methods now available.
The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.
|Official Title:||An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer|
- to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biopsy of an accessible lesion
|Study Start Date:||September 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
- To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
- To identify the frequency with which potential targets and pathways for therapy are discovered.
- To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443390
|United States, Arizona|
|Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare|
|Scottsdale, Arizona, United States, 85258|
|Principal Investigator:||Glen J Weiss, M.D.||Scottsdale Healthcare|