Integrated Cancer Repository for Cancer Research

The integrated Cancer Repository for Cancer Research (iCaRe2 http://icare2project.org) is a
unique sociotechnical resource for the collection and management of cancer and health-related
data at the Fred & Pamela Buffett Cancer Center at University of Nebraska Medical Center
(UNMC). The iCaRe2 is a multi-center, semantically-interoperable and easily-customizable
cancer data resource which is aimed at collecting, managing, mining and sharing the
comprehensive, multi-dimensional cancer-related data on cancer patients and biospecimens
(such as tumor specimens, germ line DNA, serum, urine, and plasma) collected from those
individuals.

The iCaRe2 provides: (i) a HIPAA compliant, secure, efficient and user-friendly mechanism for
data and validation; (ii) utilization of standard vocabulary and data elements; and (iii) the
ad-hoc data reporting capabilities. The iCaRe2 serves as a collaboration platform for studies
(including clinical trials) performed in centers with expertise in cancer biology, pathology,
epidemiology, genetics, early detection, and patient care.

The iCaRe2 has been developed as an expansion of the biocomputing framework that initially
included four multi-center collaborative registries:

(i) the PCCR (Pancreatic Cancer Collaborative Registry that was established in 2001), (ii)
the BCCR (Breast Cancer Collaborative Registry - established in 2006 ); (iii) the TCCR
(Thyroid Cancer Collaborative Registry - established in 2006), and (iv) the GPHID (Great
Plains Health Informatics Database - established in 2011 to enroll subjects who have no
personal history of cancer diagnosis at the time of enrollment).

At present, this framework has been incrementally expanded to include the Thoracic Oncology
Collaborative Registry (TOCR), GenitoUrinary Cancer Collaborative Registry (GUCaRe), Head and
Neck Cancer Collaborative Registry (HNCCR), Gastrointestinal & Abdominal Cavity Cancer
Collaborative Registry (GACCaRe), Central Nervous System Tumor Collaborative Registry (CTCR),
Leukemia and Myeloid Neoplasm Registry (LeMN) , Gynecological Cancer Collaborative Registry
(GCCR), Sarcoma Collaborative Registry (SARCR), Melanoma Collaborative Registry (MELCR) and
Auxiliary Cancer Registry (ACR).

The iCaRe2 group elected to use a "confederation model", as opposed to a traditional registry
or network model. It was felt that these latter models implied that the registry or network
would assume control of an individual Center's database. The major advantages of a
confederation model include the flexibility to use selected Centers for different research
projects based on a Center's resources and expertise and the ability to have different
strategies to address various research questions. It was also recognized that for this model
to be successful, it is essential to have a standardized approach to data collection (patient
information and biospecimen annotation) and reporting. A confederation would also encourage
participation of any interested Center, irrespective of its size or location. A web-based
registry iCaRe2 was developed and made available to any Center to participate in data
collection and storage of cancer related data.

Inclusion Criteria.

- Adult individuals (male and female) who have a personal diagnosis/history of cancer

- Adult individuals who have a risk for developing cancer or suspicious clinical
findings

- Adult individuals with no history of cancer for normal control registry.

- Able to provide consent.

- 19 years of age or older.

- Adult individuals who are able to speak English. Exclusion Criteria.

- Individuals under age 19.

- Individuals unable to provide informed consent by virtue of cognitive impairment.

- Anyone who does not meet the above inclusion criteria for this project.

- Non-English speaking individuals.