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, Breast Cancer, Leukemia, Melanoma, Sarcoma, Unknown Primary Tumor, Multiple Myeloma, Ovarian Cancer, Endometrial Cancer, Vaginal Cancer, Neuroendocrine Tumors, Plasma Cell Dyscrasia

status: recruiting

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

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:

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

investigators: Whitney Goldner, MD, 402-559-3579, wgoldner@unmc.edu

trial center locations: United States

• United States, Colorado
  Parker Adventist Hospital
  Kate Crow, 719-776-5270, katecrow@centura.org
  
  
• United States, Colorado
  Penrose Cancer Center
  Jodi Harr, 719-776-5270, jodiharr@centura.org
  
  
• United States, Colorado
  Porter Adventist Hospital
  Kate Crow, 719-776-5270, katecrow@centura.org
  
  
• United States, Colorado
  St. Anthony Hospital
  Kate Crow, 719-776-5270, katecrow@centura.org
  
  
• United States, Colorado
  St. Mary Corwin Medical Center
  Kate Crow, 719-776-5270, katecrow@centura.org
  
  
• United States, Florida
  Florida Hospital DeLand
  T. Windham, 386-231-3267, christopher.windham@fhmmc.org
  
  
• United States, Florida
  Florida Hospital FISH
  Sandy Allten, 386-231-4023, sandra.allten@fhmmc.org
  
  
• United States, Florida
  Florida Hospital Flagler
  Sandy Allten, 386-231-4023, sandra.allten@fhmmc.org
  
  
• United States, Florida
  Florida Hospital Memorial Medical Center
  Sandy Allten, 386-231-4023, sandra.allten@fhmmc.org
  
  
• United States, Florida
  Halifax Health Medical Center d/b/a Halifax Health
  Ruby Deveras, 386-254-4213, ruby.deveras@halifax.org
  
  
• United States, Illinois
  Rush-Copley Cancer Care Center
  Joseph Meschi, joseph.meschi@rushcopley.com
  
  
• United States, Illinois
  Rush-Copley Healthcare Center
  Amanda Baker, 630-978-6212, amanda.baker@rushcopley.com
  
  
• United States, Illinois
  Trinity Medical Center
  David Spector, 309-779-5980, hocia2000@yahoo.com
  
  
• United States, Indiana
  Community Cancer Center North
  Kelly Verel, 317-497-2836, kverel@ecommunity.com
  
  
• United States, Indiana
  Community Cancer Center South
  Kelly Verel, 317-497-2836, kverel@ecommunity.com
  
  
• United States, Indiana
  Community Health Network
  Kelly Verel, 317-497-2836, kverel@ecommunity.com
  
  
• United States, Indiana
  Community Howard Regional Hospital
  Anuj Agarwala
  
  
• United States, Indiana
  Parkview Research Center
  Neil Sharma
  
  
• United States, Iowa
  Abben Cancer Center
  Jolyn Threlkeld, 712-264-8691, jthrelkeld@spencerhospital.org
  
  
• United States, Iowa
  Covenant Medical Center, Inc
  Kim Maxfield, 319-272-2388, kimberly.maxfield@wfhc.org
  
  
• United States, Iowa
  Genesis Medical Center
  George Kovach, 563-421-1908, gkovach@iacancer.com
  
  
• United States, Iowa
  Iowa Cancer Specialists
  George Kovach
  
  
• United States, Iowa
  Methodist Jennie Edmundson Hospital
  Michael Zlomke, 712-396-4117
  
  
• United States, Kansas
  Saint Luke’s Cancer Instititue – South
  Andi Wiseman, 816-287-6057, awiseman@saint-lukes.org
  
  
• United States, Louisiana
  Tulane University
  Bridgette Collins-Burow, 504-988-6124, bcollin1@tulane.edu
  
  
• United States, Maine
  Central Maine Medical Center
  Nicholette Erickson, 207-795-8315, erickson@cmhc.org
  
  
• United States, Maryland
  Meritus Center for Clinical Research
  Michael McCormack, 301-665-4682, michael.mccormack@meritushealth.com
  
  
• United States, Maryland
  Northwest Hospital
  Flavio Kruter
  
  
• United States, Maryland
  William E Kahlert Regional Cancer Center
  Carilynn Hughes, 410-871-7450, chughes@carrollhospitalcenter.org
  
  
• United States, Massachusetts
  Beth Israel Deaconess Hospital
  Laurie Halloran, 508-732-8068, lhalloran@bidplymouth.org
  
  
• United States, Massachusetts
  Holyoke Medical Center
  Lynn Downey, 413-534-2500, downey_lynn@holyokehealth.com
  
  
• United States, Michigan
  University of Michigan Health System
  Michelle Anderson, 734-936-4775
  
  
• United States, Minnesota
  Avera Cancer Institute – Marshall
  Mark Huber, 507-537-9000, mark.huber@avera.org
  
  
• United States, Minnesota
  Essentia Health – Duluth Clinic
  Amy Hecke, amy.vanhecke@essentiahealth.org
  
  
• United States, Minnesota
  Essentia Health – St. Joseph’s Medical Center – Brainerd
  Amy Hecke, amy.vanhecke@essentiahealth.org
  
  
• United States, Minnesota
  Riverwood Healthcare Center
  Amy Hecke, amy.vanhecke@essentiahealth.org
  
  
• United States, Minnesota
  St. Luke’s Hospital of Duluth
  Karley Respet, 218-249-5002, karley.respet@slhduluth.com
  
  
• United States, Missouri
  Heartland Regional Medical Center dba Mosaic Life Care
  Robert Weigand, 816-271-7937, robert.weigand@mymlc.com
  
  
• United States, Missouri
  Mercy Hospital – Joplin
  Rita Glaze, 417-556-3076, rita.glaze@mercy.net
  
  
• United States, Missouri
  Saint Luke’s Cancer Institute
  Andi Wiseman, 816-287-6057, awiseman@saint-lukes.org
  
  
• United States, Missouri
  Saint Luke’s Cancer Institute – East
  Andi Wiseman, 816-287-6057, awiseman@saint-lukes.org
  
  
• United States, Missouri
  Saint Luke’s Cancer Institute – Kansas City North
  Andi Wiseman, 816-287-6057, awiseman@saint-lukes.org
  
  
• United States, Missouri
  Saint Luke’s Cancer Institute – Liberty
  Andi Wiseman, 816-287-6057, awiseman@saint-lukes.org
  
  
• United States, Montana
  Community Medical Center – Missoula
  Susan Nelson, 406-327-3914, snelson@communitymed.org
  
  
• United States, Montana
  Kalispell Regional Healthcare dba Glacier View Research Institute
  Melissa Hulvat, 406-752-8669, mhulvat@krmc.org
  
  
• United States, Montana
  Montana Cancer Center of Providence St. Patrick Hospital
  Michael Snyder, 406-329-5652, michael.snyder2@providence.org
  
  
• United States, Nebraska
  Avera St. Anthony’s Hospital
  Charlene Berke, 605-995-5725, charlene.berke@avera.org
  
  
• United States, Nebraska
  Faith Regional Health Services, Carson Cancer Center
  Cynthia Montgomery, 402-644-7534, cmontgome@frhs.org
  
  
• United States, Nebraska
  Great Plains Regional Medical Center
  Lisa Kosmacek, 308-696-7386, kosmacekl@gmhealth.org
  
  
• United States, Nebraska
  Mary Lanning Healthcare/Morrison Cancer Center
  Shamila Garg
  
  
• United States, Nebraska
  Methodist Estabrook Cancer Center
  Russell Smith
  
  
• United States, Nebraska
  Nebraska Methodist Health System
  Kathryn Bartz, 402-354-7939, kathryn.bartz@nmhs.org
  
  
• United States, Nebraska
  Regional West Health Services
  
  
• United States, Nebraska
  University of Nebraska Medical Center
  Whitney Goldner, 402-559-3579, wgoldner@unmc.edu
  
  
• United States, New York
  C.R. Wood Cancer Center, Glens Falls Hospital
  Beth Brundage, 518-926-6701, bbrundage@glensfallshosp.org
  
  
• United States, New York
  Faxton St. Luke’s Healthcare/Mohawk Valley
  Atul Butala, 315-624-5705, utica.oncology@yahoo.com
  
  
• United States, New York
  St. Peter’s Hospital
  Ami Negandhi, 518-525-5087, ami.negandhi@sphp.com
  
  
• United States, North Carolina
  Cape Fear Valley Health System
  Kenneth Manning
  
  
• United States, North Dakota
  Essentia Health – Fargo
  Joni Buechler-Price, 218-786-1018, joni.buechler-price@essentiahealth.org
  
  
• United States, North Dakota
  Trinity Hospital Cancer Care Center
  Nadia Smetana, 701-857-3174, nadia.smetana@trinityhealth.org
  
  
• United States, Pennsylvania
  University of Pittsburgh
  Randall Brand, 412-623-4124
  
  
• United States, South Dakota
  Avera Cancer Institute – Mitchell
  Joni Sevigny, 605-995-5725, joni.sevigny@avera.org
  
  
• United States, South Dakota
  Avera Cancer Institute – Sioux Falls
  Amy Krie, 605-322-7600
  
  
• United States, South Dakota
  Avera Cancer Institute – Yankton
  Charlene Berke, 605-995-5725, charlene.berke@avera.org
  
  
• United States, South Dakota
  Avera Medical Group Oncology and Hematology Aberdeen
  Cari Price, 605-622-5613, cari.price@avera.org
  
  
• United States, South Dakota
  Sanford Health
  William Spanos, 605-328-8200
  
  
• United States, Vermont
  Rutland Regional Medical Center
  Rebecca Denofer, 802-747-1692, rdenofer@rrmc.org
  
  
• United States, Wisconsin
  Ascension Mercy Hospital
  Dale Grimmer, 920-831-1245, dale.grimmer@ascension.org
  
  
• United States, Wisconsin
  Ascension St. Elizabeth Hospital
  Dale Grimmer, 920-831-1245, dale.grimmer@ascension.org
  
  
• United States, Wisconsin
  Columbia St. Mary’s – Mequon
  Lorna Rogahn, lorna.rogahn@ascension.org
  
  
• United States, Wisconsin
  Columbia St. Mary’s – Milwaukee
  Bobby Paul, bobby.paul@ascension.org
  
  
• United States, Wisconsin
  Wheaton Franciscan Healthcare – All Saints
  Michelle Czechowicz, 262-687-5057, michelle.czechowicz@wfhc.org
  
  
• United States, Wisconsin
  Wheaton Franciscan Healthcare – Elmbrook Memorial Hospital
  Meghan Terry, 262-780-4347, meghan.terry@wfhc.org
  
  
• United States, Wisconsin
  Wheaton Franciscan Healthcare – Reiman Cancer Care
  Jonathan Treisman, 414-427-2360, jonathan.treisman@wfhc.org
  
  
• United States, Wisconsin
  Wheaton Franciscan Healthcare – Wauwatosa Cancer Care
  Pamela Phillips, 414-259-7486, pamela.phillips@wfhc.org