Scientific & Clinical Resources Overview
Total Cancer CareTM is the Center’s comprehensive approach to cancer that enables researchers and care-givers to identify and meet all the needs of a patient and his or her family during the patient’s lifetime and for future generations. A major component of Total Cancer Care is Personalized Cancer Care. Key elements of this approach to cancer include:
- New partnerships for research, data and tissue collection, and cancer care delivery
- A protocol-specific Tissue Bank and Data Warehouse
- Portals to the Data Warehouse to benefit clinicians, researchers and patients
- Partnerships with patients for life through participation in the Total Cancer Care Protocol
Implementing Total Cancer Care requires an extensive infrastructure to collect, organize, evaluate and disseminate a vast amount of information. It is the broad scope that makes Total Cancer Care unique and offers the potential for changing the standard of care. The building blocks of Total Cancer Care include the following:
- Consortium Partners - Moffitt Cancer Center, an NCI-Designated Comprehensive Cancer Center based in Tampa, Florida, provides the overall leadership of the effort and strong institutional commitment. However, the success of Total Cancer Care is the collective contributions of the 17 partners spread throughout Florida and the nation. Total Cancer Care’s success is dependent on broad and active participation by all partners. The partnership consists of a large state, national and international network of community hospitals and academic and research partners. All work together to meet the goals of Total Cancer Care, with each partner actively consenting patients, collecting specimens and collecting clinical data.
- A single protocol - Patient participation and interest is the single most critical component of Total Cancer Care. A single protocol was developed to specifically address the needs of Total Cancer Care for tissue collection and longitudinal data collection over a patient’s lifetime through a safe, efficient and consistent process. The IRB-approved protocol is opened to each consortium site. More than 50,000 patients to date have consented to be part of Total Cancer Care and 100,000 are expected to have enrolled within a year. With lifetime prospective follow-up and a patient portal, patients are active participants.
- Lifetime prospective follow-up: evaluating the effectiveness of TCC 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 - A large network of centers, universities and community hospitals all 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 – Total Cancer Care 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. Shipped to M2Gen, a Total Cancer Care partner, 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.