Clinical trial NCT02012699: Integrated Cancer Repository for Cancer Research
Official title: Integrated Cancer Repository for Cancer Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Thyroid Cancer
Lung Cancer
Esophageal Cancer
Thymus Cancer
Colon Cancer
Rectal Cancer
Gastrointestinal Stromal Tumors
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
Central Nervous System Tumor
Central Nervous System Cancer
Mesothelioma
Breast Cancer
Leukemia
Melanoma
Sarcoma
Unknown Primary Tumor
Multiple Myeloma
Ovarian Cancer
Endometrial Cancer
Vaginal Cancer
Neuroendocrine Tumors
Plasma Cell Dyscrasia
Healthy Control
Keywords: Pancreatic Cancer
Thyroid Cancer
Esophageal cancer
Thymus cancer
Pancreatic tumor
Esophageal tumor
Thymus tumor
Thyroid Tumor
Thyroid Nodule
Lung Tumor
Breast Cancer
Neuroendocrine tumor
Plasma Cell Dyscrasia
Healthy Control
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 999999
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual who meets the eligibility criteria will be invited to participate in iCaRe2.

Brief summary: 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.

Detailed description: The integrated Cancer Repository for Cancer Research (iCaRe2 http://icare2.unmc.edu) 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 has been developed as an expansion of the biocomputing framework that initially included four multi-center collaborative registries: Pancreatic Cancer Collaborative Registry (PCCR), Breast Cancer Collaborative Registry (BCCR), Thyroid Cancer Collaborative Registry (TCCR), and Great Plains Health Informatics Database (GPHID; to enroll subjects with no history of cancer diagnosis at time of enrollment). The repository now includes: 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), Plasma Cell Dyscrasias Collaborative Registry (PDCR), Neuroendocrine Collaborative Registry (NETR), Non-Melanoma Skin Cancer Registry (NMSC) and Auxiliary Cancer Registry (ACR).

The iCaRe2 group elected to use a "confederation model", as opposed to a traditional registry or network model. 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. A web-based registry iCaRe2 was developed and made available to any Center to participate in data collection and storage of cancer related data. The iCaRe2 provides a HIPAA compliant, secure, efficient and user-friendly mechanism for data and validation; utilization of standard vocabulary and data elements; and 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.

Eligibility criteria: Inclusion Criteria

* Diagnosis/history of cancer
* Risk for developing cancer or suspicious clinical findings
* No history of cancer (normal control registry)
* Able to provide informed consent
* 19 years of age or older
* English or Spanish speaking individuals

Exclusion Criteria

* Unable to provide informed consent because of cognitive impairment
* Non-English or non-Spanish speaking individuals

Primary outcomes:
measure: Development and Implementation of a Web-based Cancer Collaborative Registry
timeFrame: 86 years
Secondary outcomes:
measure: Procurement and Banking of Excess Biological Material for Future Analysis
timeFrame: 86 years
Other outcomes:
measure: Collection and Banking of Blood, DNA, and Urine Samples for Future Studies
timeFrame: 86 years
Locations:
city: Greenwood Village
country: United States
facility: Advent Health
state: Colorado
city: Daytona Beach
country: United States
facility: Florida Hospital Memorial Medical Center
state: Florida
city: DeLand
country: United States
facility: Florida Hospital DeLand
state: Florida
city: Orange City
country: United States
facility: Florida Hospital FISH
state: Florida
city: Palm Coast
country: United States
facility: Florida Hospital Flagler
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Yorkville
country: United States
facility: Rush-Copley Healthcare Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Community Cancer Center South
state: Indiana
city: Council Bluffs
country: United States
facility: Methodist Jennie Edmundson Hospital
state: Iowa
city: Waterloo
country: United States
facility: Covenant Medical Center, Inc
state: Iowa
city: Overland Park
country: United States
facility: Saint Luke's Cancer Instititue - South
state: Kansas
city: Randallstown
country: United States
facility: Northwest Hospital
state: Maryland
city: Westminster
country: United States
facility: William E Kahlert Regional Cancer Center
state: Maryland
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Aitkin
country: United States
facility: Riverwood Healthcare Center
state: Minnesota
city: Brainerd
country: United States
facility: Essentia Health-St. Joseph's Medical Center
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health - Duluth Clinic
state: Minnesota
city: Duluth
country: United States
facility: St. Luke's Hospital of Duluth
state: Minnesota
city: Fergus Falls
country: United States
facility: Lake Region Healthcare
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute, East
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute, Kansas City North
state: Missouri
city: Liberty
country: United States
facility: Saint Luke's Cancer Institute, Liberty
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center dba Mosaic Life Care
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Kalispell
country: United States
facility: Logan Health
state: Montana
city: Hastings
country: United States
facility: Mary Lanning Healthcare, Morrison Cancer Center
state: Nebraska
city: Norfolk
country: United States
facility: Faith Regional Health Services, Carson Cancer Center
state: Nebraska
city: North Platte
country: United States
facility: Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Health System
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Scottsbluff
country: United States
facility: Regional West Health Services
state: Nebraska
city: Glens Falls
country: United States
facility: C.R. Wood Cancer Center, Glens Falls Hospital
state: New York
city: Utica
country: United States
facility: Faxton St. Luke's Healthcare, Mohawk Valley
state: New York
city: Fayetteville
country: United States
facility: Cape Fear Valley Health System
state: North Carolina
city: Fargo
country: United States
facility: Essentia Health
state: North Dakota
city: Minot
country: United States
facility: Trinity Hospital Cancer Care Center
state: North Dakota
city: Alliance
country: United States
facility: Aultman Alliance Community Hospital
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Rutland
country: United States
facility: Rutland Regional Medical Center
state: Vermont
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
Study officials:
affiliation: University of Nebraska
name: Quan Ly, MD
role: PRINCIPAL_INVESTIGATOR
References: