Making personalized medicine a reality: practical lessons from a next generation sequencing-driven clinical trial in pancreatic cancer — ASN Events
  1. Schedule
  2. Poster Review
  3. Making personalized medicine a reality: practical lessons from a next generation sequencing-driven clinical trial in pancreatic cancer

Making personalized medicine a reality: practical lessons from a next generation sequencing-driven clinical trial in pancreatic cancer (#23)

Clare Watson 1 , Anthony Gill 2 3 , Mona Martyn-Smith 1 , Lorraine Chantrill 1 4 , Scott Mead 1 5 , Nicole Watson 2 , Nik Zeps 6 , Andrew Biankin 1 , Amber Johns 1
  1. Garvan Institute of Medical Research, Darlinghurst, Sydney, NSW, Australia
  2. Department of Anatomical Pathology, Royal North Shore Hospital, St Leonards, Sydney, NSW, Australia
  3. Sydney Medical School, University of Sydney, Sydney, NSW, Australia
  4. Macarthur Cancer Therapy Centre, Campbelltown, NSW, Australia
  5. Department of Anatomical Pathology, St Vincent's Hospital, Darlinghurst, Sydney, NSW, Australia
  6. St John of God Healthcare, Perth, WA, Australia

On behalf of the Australian Pancreatic Cancer Genome Initiative (APGI) and the IMPaCT Trial Management Committee

Background

Next generation sequencing is providing unprecedented opportunities to uncover the underlying genetic pathways driving cancer and is accelerating the drive towards personalized medicine. Human specimens that are analysed using these technology platforms are a critical resource for basic and translational research in cancer because they are a direct source of molecular data from which targets for therapy, detection, and prevention are identified. Similarly, clinical trials are increasingly designed based on molecular characteristics uncovered by genomic technologies, further fueling the demand for high-quality, well-annotated biospecimens.

The logistics and infrastructure required to retrieve, process and manage suitable biospecimens is often overlooked when budgeting and planning for such efforts. Furthermore, technology, advancements in molecular knowledge and globalization are destroying traditional biobanking models, stimulating a shift in capability from collecting and archiving samples for future use, to enabling routine processing of biospecimens in real time for therapeutic or clinical trial purposes.

Methods and Results

We describe experiences from the pilot stage of the Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) trial, a collaboration between the APGI, AGITG and the CTC, which is a unique biopsy-driven, molecularly guided clinical trial in patients with recurrent or metastatic pancreatic cancer. We provide a quantitative assessment of the pre-analytical workflow; including turnaround times, and quality metrics. We discuss some of the challenges involved; including coordinating sample retrieval with clinical departments, optimal biospecimen types, analyte extraction using minimal and heterogeneous samples, quality control and return of results.

Discussion

We highlight the human and technical aspects of conducting these complex enterprises to ensure an efficient and high quality process. We also make comment on the innovative methods we have employed specific to such situations where the stakes are high and the timeline is critical.