The International Association for the Study of Lung Cancer Early Lung Imaging Confederation.

PURPOSE: To improve outcomes for lung cancer through low-dose computed tomography (LDCT) early lung cancer detection. The International Association for the Study of Lung Cancer is developing the Early Lung Imaging Confederation (ELIC) to serve as an open-source, international, universally accessible environment to analyze large collections of quality-controlled LDCT images and associated biomedical data for research and routine screening care. METHODS: ELIC is an international confederation that allows access to efficiently analyze large numbers of high-quality computed tomography (CT) images with associated de-identified clinical information without moving primary imaging/clinical or imaging data from its local or regional site of origin. Rather, ELIC uses a cloud-based infrastructure to distribute analysis tools to the local site of the stored imaging and clinical data, thereby allowing for research and quality studies to proceed in a vendor-neutral, collaborative environment. ELIC's hub-and-spoke architecture will be deployed to permit analysis of CT images and associated data in a secure environment, without any requirement to reveal the data itself (ie, privacy protecting). Identifiable data remain under local control, so the resulting environment complies with national regulations and mitigates against privacy or data disclosure risk. RESULTS: The goal of pilot experiments is to connect image collections of LDCT scans that can be accurately analyzed in a fashion to support a global network using methodologies that can be readily scaled to accrued databases of sufficient size to develop and validate robust quantitative imaging tools. CONCLUSION: This initiative can rapidly accelerate improvements to the multidisciplinary management of early, curable lung cancer and other major thoracic diseases (eg, coronary artery disease and chronic obstructive pulmonary disease) visualized on a screening LDCT scan. The addition of a facile, quantitative CT scanner image quality conformance process is a unique step toward improving the reliability of clinical decision support with CT screening worldwide.

Lung Cancer Workshop XI: Tobacco-Induced Disease: Advances in Policy, Early Detection and Management.

The Prevent Cancer Foundation Lung Cancer Workshop XI: Tobacco-Induced Disease: Advances in Policy, Early Detection and Management was held in New York, NY on May 16 and 17, 2014. The two goals of the Workshop were to define strategies to drive innovation in precompetitive quantitative research on the use of imaging to assess new therapies for management of early lung cancer and to discuss a process to implement a national program to provide high quality computed tomography imaging for lung cancer and other tobacco-induced disease. With the central importance of computed tomography imaging for both early detection and volumetric lung cancer assessment, strategic issues around the development of imaging and ensuring its quality are critical to ensure continued progress against this most lethal cancer.

Using patient-initiated study participation in the development of evidence for personalized cancer therapy.

Personalized cancer therapy offers the promise of delivering the right treatments to the right patients to improve patient outcomes and quality of life, while reducing exposure to ineffective therapies and the cost of cancer care. Realizing this promise depends in large part on our ability to generate timely and sufficiently detailed information regarding factors that influence treatment response. Generating this evidence through the traditional physician investigator-initiated clinical trial system has proved to be challenging, given poor recruitment rates and low compliance with requests for biospecimen collection. As a result, our current understanding of treatment response is inadequate, particularly for cancer therapies that have been in use for many years. Patient-initiated study participation may offer a new model for evidence generation that capitalizes on strong patient interest in furthering research to inform better and more tailored cancer therapies. In this approach, patients are engaged and recruited directly by the sponsor of an Institutional Review Board-approved study, and patients subsequently drive the participation of their health care providers to facilitate collection of required data and tissue samples. The ultimate goal of these studies is to generate evidence of sufficient quality to inform regulatory decisions (i.e., labeling changes for marketed therapies to reflect populations most likely to respond) and treatment selection. Here, we describe a hypothetical prospective observational study in non-small cell lung cancer that could serve as a model for patient-initiated study participation applied to understand molecular determinants of treatment response. Key elements discussed include study design, patient engagement, and data/biospecimen collection and management principles.