Integrated Cancer Repository for Cancer Research (iCaRe2)

study id #: NCT02012699

condition: Pancreatic Cancer, Thyroid Cancer, Lung Cancer, Esophageal Cancer, Thymus Cancer, Colon Cancer, Rectal Cancer, GIST, Anal Cancer, Bile Duct Cancer, Duodenal Cancer, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Small Intestine Cancer, Peritoneal Surface Malignancies, Familial Adenomatous Polyposis, Lynch Syndrome, Bladder Cancer, Kidney Cancer, Penile Cancer, Prostate Cancer, Testicular Cancer, Ureter Cancer, Urethral Cancer, Hypopharyngeal Cancer, Laryngeal Cancer, Lip Cancer, Oral Cavity Cancer, Nasopharyngeal Cancer, Oropharyngeal Cancer, Paranasal Sinus Cancer, Nasal Cavity Cancer, Salivary Gland Cancer, Skin Cancer, CNS Tumor, CNS Cancer, Mesothelioma, Breastcancer, Leukemia, Melanoma, Sarcoma, Unknown Primary Tumor, Multiple Myeloma, Ovarian Cancer, Endometrial Cancer, Vaginal Cancer

status: recruiting

The objectives of this project at UNMC and other IRB approved sites is to implement and maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core support services for future IRB approved multidisciplinary research on cancer and other chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well as internal and external research collaborators from different participating institutions/centers.

start date: November 2013

estimated completion: December 2099

last updated: November 5, 2018

size / enrollment: 9999

study design: Observational Model: Cohort
Time Perspective: Prospective

study description:
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.

primary outcomes:

• Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC) [ Time Frame: 25 years ]
  This is a registry that will continue to accrue patients indefinitely

secondary outcomes:

• Procurement and banking of excess biological material for future analysis [ Time Frame: 25 years ]
  This is a registry and biobank and will continue to accrue indefinitely

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.

sponsor: University of Nebraska

contacts:
Whitney Goldner MD, 402-559-3579, wgoldner@unmc.edu
Michelle Desler MS, 402-559-8885, mdesler@unmc.edu

investigators: Whitney Goldner, MD

locations: United States, Italy