The Total Cancer Care Study is at the heart of an integrated approach to following the patient through his or her lifetime and relies on a network of health care providers who contribute and share information from individual patients. In order to meet the needs of the patient, Total Cancer Care must also meet the needs of the researcher and do so in an innovative way, which was never before possible. To support your research, Total Cancer Care requires an extensive infrastructure to collect, organize, evaluate and disseminate a vast amount of information. It is the broad scope and depth of information that makes Total Cancer Care unique and offers the potential for changing the standard of care.
A few of the Total Cancer Care components are critical to effective research and include:
- Lifetime prospective follow-up: evaluating the effectiveness of Total Cancer Care is critical to developing and evaluating the quality of care. Follow-up will allow for the development of biomarkers, epidemiological studies and the development of evidence-based practice guidelines. Data related to survivorship will also be collected and are of added importance to patients and their ongoing needs.
- Information Technology and Process Solutions – The consortium of health care providers collecting information while maintaining HIPAA compliance requires state-of-the-art technology solutions for data collection, storage, dissemination, correlation and analysis on a very large scale. The solutions require efficiency and uniformity for success. To meet these needs, standard operating procedures (SOPs) were developed and are applied across all Total Cancer Care consortium members to ensure uniformity and consistent data collection in an ethical manner. Some examples of these process and technology based solutions include:
- Centralized Tissue Banking – The Total Cancer Care Study collects tumor, blood and urine samples as well as clinical data such as risk factors, therapies and outcomes. All tissues are snap-frozen within 15 minutes and 2D bar code labeled and shipped to M2Gen, the company that manages the Total Cancer Care Study for the consortium. M2Gen ensures every tissue is macrodissected to 85% purity and quantified for the percent of malignancy, cellularity, stroma, normalcy and necrosis. To date, more than 100,000 specimens have been gathered including nearly 10,000 solid tumors and more than 82,000 liquid samples including bone marrow, whole blood, plasma and urine. This number will grow exponentially in coming years.
- A large Biorepository is critical for the collection and storage of samples. All samples collected under the Total Cancer Care protocol are stored in a single location. A large biobank, based in Tampa, will store 120,000 samples. The biobank is part of 50,000 square feet of dedicated space for Total Cancer Care that opened in March 2009. An oversight committee and detailed operation procedures ensure proper access and use of tissue, including meeting all HIPAA requirements.
- Multi-dimensional Data Warehouse - Moffitt Cancer Center in collaboration with M2Gen has established a data warehouse to collect, relate and interpret clinical data and molecular data from patients. The warehouse includes but is not limited to consortium data, patient records, medical history, registry data, molecular profiles, gene expression data and clinicopathologic data. All data is stored and utilized in compliance with HIPAA requirements. Within a year, the warehouse is expected to hold information on primary and metastatic biopsies for more than 50,000 patients. The longitudinal database has more than 500 million independent events stored. Currently the warehouse is over 1 terabyte of data, 30 terabytes if images are counted. Within five years, it is expected to easily surpass 10 terabytes of data. Appropriate access is given to the patient, the clinician and researcher to lead to the creation of evidence-based guidelines. Three separate Web-based portals are in various stages of development to meet these distinct needs.
Reflecting the goal of Total Cancer Care to meet all of the needs of the patient, research involving the Total Cancer Care Study covers all aspects of a cancer patient’s life journey. Total Cancer Care offers great potential to you, the researcher, since you can leverage the vast amount of information in the data warehouse and tissue repository. Innovative research based on the Total Cancer Care Study includes:
- New imaging modalities to develop better diagnostic tools
- Utilizing genetic and molecular information for genomics, proteomics and nanotechnology projects to better understand the causes of cancer that may lead to improving diagnosis and prognosis
- Developing personalized multimodality therapies for more effective treatment options
- Developing clinical trials based on new drugs or innovative treatment regimens for patients that are more likely to respond to specialized treatment.
- Patient-centered outcomes research that better meets the ongoing needs of survivors and their families
- Developing studies and evaluating risk factors, genetic predispositions, early detection and health disparities to better understand the multiple factors they contribute to risk
- Evaluating the most effective ways to prevent cancer by studying the impact of factors such as lifestyle, nutrition and education
Access to Total Cancer Care for research is limited under the specific terms of each the Consortium Member. Once those criteria have been established, a “Data Concierge” is available to assist you through all steps of the approval process and access requirements. For more information about utilizing Total Cancer Care for research, contact the Total Cancer Care Consortium.