Scientific and Clinical Resources Overview

At Moffitt Cancer Center, the Total Cancer Care^® (TCC) research protocol is a way that we can partner with patients and non-Moffitt patients with the goals of using longitudinally collected data and biospecimens to (1) identify the needs of the patient and their families; (2) develop an evidence-based approach to meet those needs; and (3) develop markers to predict need so they can be prevented.

To achieve these goals, the protocol objectives are as follows:

• Establish a longitudinal study of clinical and related data from individuals with or at risk for cancer 
• Establish a large biospecimen repository that is linked to clinical and related data 
• Follow participants through their lifetime through passive or active follow-up 
• Use clinical data, tissues, other biological samples and derived molecular data to match patients to future studies either observational studies or intervention/clinical trials

By tracking and studying information from participants, the study is helping to change the way doctors prevent, detect and treat cancer. The valuable information can come from patients' donated blood and tissue samples, medical information, or questionnaires.

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 research that will change the standard of care. The building blocks of Total Cancer Care include the following:

• Patients: Patient participation and interest is the single most critical component of Total Cancer Care. A single protocol was developed to provide tissue collection and longitudinal data collection over a patient’s lifetime through a safe, efficient and consistent process. More than 175,000 patients have consented to be part of Total Cancer Care and are active participants in changing the way we think about cancer.
• One Protocol: A unique and comprehensive protocol focused on the collection of blood, tissue, other biological samples and patient data from surveys, medical records, cancer registry data and other related data from medical histories.
• Centralized Tissue Banking: Total Cancer Care can collect tumor, blood and other biological samples as well as clinical data such as risk factors, therapies and outcomes. To date, more than 100,000 specimens have been gathered including nearly solid tumors and liquid samples including bone marrow, whole blood, plasma and urine. This number will grow exponentially in the coming years.
• The physical Biorepository is critical for the collection and storage of samples. All samples collected under the Total Cancer Care protocol are managed by the Moffitt Cancer Center College of Pathology accredited Tissue Core Shared Resource. An oversight committee and detailed operational procedures ensure proper access and use of tissue, including meeting all HIPAA requirements.
• Lifetime prospective follow-up: Lifetime partnership with patients is critical to developing and evaluating the quality of care. Through this study, patients share medical histories, may complete surveys and may be asked to participate in studies tied to Total Cancer Care. Follow-up will allow for the development of biomarkers, epidemiological studies and the development of evidence-based practice guidelines. Data related to survivorship is collected and is of added importance to patients and their ongoing needs.
• Research Partnerships: In order to meet the needs of researchers and provide a world-class infrastructure, Total Cancer Care has developed an innovative business model that includes research partnerships with patients, research centers, academic institutions and industry including the partnership through ORIEN. Bringing together patients, research and doctors, enables us to change the way we think about cancer.
• Multi-dimensional Data Warehouse – Moffitt Cancer Center 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 community partner site 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. Appropriate access is given to the clinician and researcher to lead to the creation of evidence-based guidelines with guidance provided by honest brokers.
• Oncology Research Information Exchange Network(ORIEN) - Moffitt has been a leader in cancer research by creating a network of top cancer centers in ORIEN that share information in a way that’s never been done. ORIEN is a growing alliance of leading cancer centers committed to speeding up research through collaboration and access to shared patient data. The more diverse our patient population, the more connections we can make.  Collaboration across ORIEN TCC sites includes sharing both clinical and molecular data from patients enrolled in the study to enhance discovery and create evidence of what is the most effective therapy for individual patients.