iCaRe2: Integrated Cancer Repository for Cancer Research

Sponsor

University of Nebraska (Other)

Overall Status

Recruiting

CT.gov ID

NCT02012699

Collaborator

(none)

999,999

Enrollment

Locations

1033

Anticipated Duration (Months)

12345.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Healthy Control

Detailed 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), Plasma Cell Dyscrasias Collaborative Registry (PDCR), Neuroendocrine Collaborative Registry (NETR), 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

999999 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Integrated Cancer Repository for Cancer Research

Actual Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2099

Anticipated Study Completion Date :

Dec 1, 2099

Outcome Measures

Primary Outcome Measures

Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC) [50 years]
This is a registry that will continue to accrue patients indefinitely

Secondary Outcome Measures

Procurement and banking of excess biological material for future analysis [50 years]
This is a registry and biobank and will continue to accrue indefinitely

Other Outcome Measures

Collection and banking of blood, DNA, and urine samples for future analysis that will be proposed in future IRB submissions [50 years]
This is a registry with biobank and accrual will continue indefinitely

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penrose Cancer Center	Colorado Springs	Colorado	United States	80907
2	Porter Adventist Hospital	Denver	Colorado	United States	80210
3	Mercy Regional Medical Center	Durango	Colorado	United States	81301
4	St. Anthony Hospital	Lakewood	Colorado	United States	80228
5	Littleton Cancer Center	Littleton	Colorado	United States	80122
6	Longmont Cancer Center	Longmont	Colorado	United States	80501
7	Avista Cancer Center	Louisville	Colorado	United States	80027
8	Parker Adventist Hospital	Parker	Colorado	United States	80138
9	St. Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
10	St. Anthony North Cancer Center	Westminster	Colorado	United States	80228
11	Florida Hospital Memorial Medical Center	Daytona Beach	Florida	United States	32117
12	Florida Hospital DeLand	DeLand	Florida	United States	32720
13	Florida Hospital FISH	Orange City	Florida	United States	32763
14	Florida Hospital Flagler	Palm Coast	Florida	United States	32164
15	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
16	Trinity Medical Center	Moline	Illinois	United States	61265
17	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
18	Parkview Research Center	Fort Wayne	Indiana	United States	46845
19	Community Health Network	Indianapolis	Indiana	United States	46219
20	Community Cancer Center South	Indianapolis	Indiana	United States	46227
21	Community Cancer Center North	Indianapolis	Indiana	United States	46256
22	Community Howard Regional Hospital	Kokomo	Indiana	United States	46902
23	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa	United States	51503
24	Genesis Medical Center	Davenport	Iowa	United States	52804
25	Abben Cancer Center	Spencer	Iowa	United States	51301
26	Covenant Medical Center, Inc	Waterloo	Iowa	United States	50702
27	Saint Luke's Cancer Instititue - South	Overland Park	Kansas	United States	66213
28	Tulane University	New Orleans	Louisiana	United States	70112
29	Breast Care Specialists of Maine	Portland	Maine	United States	04102
30	Northwest Hospital	Randallstown	Maryland	United States	21133
31	William E Kahlert Regional Cancer Center	Westminster	Maryland	United States	21157
32	Holyoke Medical Center	Holyoke	Massachusetts	United States	01040
33	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
34	Riverwood Healthcare Center	Aitkin	Minnesota	United States	56431
35	Essentia Health-St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
36	Essentia Health - Duluth Clinic	Duluth	Minnesota	United States	55805
37	St. Luke's Hospital of Duluth	Duluth	Minnesota	United States	55805
38	Lake Region Healthcare	Fergus Falls	Minnesota	United States	56537
39	Avera Cancer Institute- Marshall	Marshall	Minnesota	United States	56258
40	Mercy Hospital - Joplin	Joplin	Missouri	United States	64804
41	Saint Luke's Cancer Institute - East	Kansas City	Missouri	United States	64086
42	Saint Luke's Cancer Institute	Kansas City	Missouri	United States	64111
43	Saint Luke's Cancer Institute - Kansas City North	Kansas City	Missouri	United States	64118
44	Saint Luke's Cancer Institute - Liberty	Liberty	Missouri	United States	64068
45	Heartland Regional Medical Center dba Mosaic Life Care	Saint Joseph	Missouri	United States	64507
46	Bozeman Health Deaconess Hospital	Bozeman	Montana	United States	59715
47	Logan Health	Kalispell	Montana	United States	59901
48	Providence St. Patrick Hospital Montana Cancer Center	Missoula	Montana	United States	59802
49	Mary Lanning Healthcare/Morrison Cancer Center	Hastings	Nebraska	United States	68901
50	Faith Regional Health Services, Carson Cancer Center	Norfolk	Nebraska	United States	68701
51	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69101
52	Avera St. Anthony's Hospital	O'Neill	Nebraska	United States	68763
53	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
54	Nebraska Methodist Health System	Omaha	Nebraska	United States	68114
55	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
56	Regional West Health Services	Scottsbluff	Nebraska	United States	69361
57	C.R. Wood Cancer Center, Glens Falls Hospital	Glens Falls	New York	United States	12801
58	Faxton St. Luke's Healthcare/Mohawk Valley	Utica	New York	United States	13501
59	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28304
60	Essentia Health	Fargo	North Dakota	United States	58103
61	Trinity Hospital Cancer Care Center	Minot	North Dakota	United States	58701
62	Aultman Alliance Community Hospital	Alliance	Ohio	United States	44601
63	Aultman Hospital	Canton	Ohio	United States	44710
64	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15323
65	Avera Medical Group Oncology and Hematology Aberdeen	Aberdeen	South Dakota	United States	57401
66	Avera Cancer Institute	Mitchell	South Dakota	United States	57301
67	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
68	Sanford Health	Sioux Falls	South Dakota	United States	57105
69	Avera Cancer Center Yankton	Yankton	South Dakota	United States	57078
70	Avera Sacred Heart Hospital	Yankton	South Dakota	United States	57078
71	Yankton Medical Clinic	Yankton	South Dakota	United States	57078
72	Rutland Regional Medical Center	Rutland	Vermont	United States	05701
73	Mary Washington Hospital	Fredericksburg	Virginia	United States	22401
74	Ascension St. Elizabeth Hospital	Appleton	Wisconsin	United States	54915
75	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin	United States	53045
76	Wheaton Franciscan Healthcare - Reiman Cancer Care	Franklin	Wisconsin	United States	53132
77	Columbia St. Mary's	Mequon	Wisconsin	United States	53097
78	Columbia St. Mary's	Milwaukee	Wisconsin	United States	53211
79	Ascension Mercy Hospital	Oshkosh	Wisconsin	United States	54904
80	Wheaton Franciscan Healthcare - All Saints	Racine	Wisconsin	United States	53405
81	Wheaton Franciscan Healthcare - Wauwatosa Cancer Care	Wauwatosa	Wisconsin	United States	53226