Integrated Cancer Repository for Cancer Research

Breast Cancer Clinical Trial

— iCaRe2  

Official title:

Integrated Cancer Repository for Cancer Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02012699
• Other study ID #: 0253-13-EP
• Status: Recruiting
• Start date: November 1, 2013
• Est. completion date: December 2099

Study information

• Verified date: February 2024
• Source: University of Nebraska
• Contact: Ken Cowan, MD
• Phone: 402-559-4238
• Email: kcowan[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 Pancreatic Cancer Collaborative Registry (PCCR) established in 2001, (ii) the Breast Cancer Collaborative Registry (BCCR) established in 2006, (iii) the Thyroid Cancer Collaborative Registry (TCCR) established in 2006, and (iv) the Great Plains Health Informatics Database (GPHID) 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.

Other known NCT identifiers

• NCT00693368

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999999
• Est. completion date: December 2099
• Est. primary completion date: December 2099
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Anal Cancer
• Anus Neoplasms
• Bile Duct Cancer
• Bile Duct Neoplasms
• Bladder Cancer
• Breast Cancer
• Central Nervous System Cancer
• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Colon Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Duodenal Cancer
• Duodenal Neoplasms
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Familial Adenomatous Polyposis
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Gastrointestinal Stromal Tumors
• Healthy Control
• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Intestinal Neoplasms
• Kidney Cancer
• Laryngeal Cancer
• Laryngeal Neoplasms
• Leukemia
• Lip Cancer
• Lip Neoplasms
• Liver Cancer
• Lung Cancer
• Lynch Syndrome
• Melanoma
• Mesothelioma
• Mouth Neoplasms
• Multiple Myeloma
• Nasal Cavity Cancer
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Neoplasms
• Neoplasms, Plasma Cell
• Neoplasms, Unknown Primary
• Nervous System Neoplasms
• Neuroendocrine Tumors
• Oral Cavity Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Paranasal Sinus Cancer
• Paranasal Sinus Neoplasms
• Paraproteinemias
• Penile Cancer
• Penile Neoplasms
• Peritoneal Neoplasms
• Peritoneal Surface Malignancies
• Plasma Cell Dyscrasia
• Prostate Cancer
• Rectal Cancer
• Salivary Gland Cancer
• Salivary Gland Neoplasms
• Sarcoma
• Skin Cancer
• Small Intestine Cancer
• Testicular Cancer
• Testicular Neoplasms
• Thymus Cancer
• Thymus Neoplasms
• Thyroid Cancer
• Thyroid Neoplasms
• Unknown Primary Tumor
• Ureter Cancer
• Ureteral Neoplasms
• Urethral Cancer
• Urethral Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms

Locations

Country	Name	City	State
United States	Avera Medical Group Oncology and Hematology Aberdeen	Aberdeen	South Dakota
United States	Riverwood Healthcare Center	Aitkin	Minnesota
United States	Aultman Alliance Community Hospital	Alliance	Ohio
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Ascension St. Elizabeth Hospital	Appleton	Wisconsin
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Essentia Health-St. Joseph's Medical Center	Brainerd	Minnesota
United States	Bristol Health Beekley	Bristol	Connecticut
United States	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin
United States	Aultman Hospital	Canton	Ohio
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa
United States	Genesis Medical Center	Davenport	Iowa
United States	Florida Hospital Memorial Medical Center	Daytona Beach	Florida
United States	Florida Hospital DeLand	DeLand	Florida
United States	Porter Adventist Hospital	Denver	Colorado
United States	Essentia Health - Duluth Clinic	Duluth	Minnesota
United States	St. Luke's Hospital of Duluth	Duluth	Minnesota
United States	Mercy Regional Medical Center	Durango	Colorado
United States	Essentia Health	Fargo	North Dakota
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Lake Region Healthcare	Fergus Falls	Minnesota
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Wheaton Franciscan Healthcare, Reiman Cancer Care	Franklin	Wisconsin
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	C.R. Wood Cancer Center, Glens Falls Hospital	Glens Falls	New York
United States	Bellin Memorial Hospital	Green Bay	Wisconsin
United States	Mary Lanning Healthcare, Morrison Cancer Center	Hastings	Nebraska
United States	Holyoke Medical Center	Holyoke	Massachusetts
United States	Community Cancer Center North	Indianapolis	Indiana
United States	Community Cancer Center South	Indianapolis	Indiana
United States	Community Health Network	Indianapolis	Indiana
United States	Mercy Hospital - Joplin	Joplin	Missouri
United States	Logan Health	Kalispell	Montana
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	Saint Luke's Cancer Institute, East	Kansas City	Missouri
United States	Saint Luke's Cancer Institute, Kansas City North	Kansas City	Missouri
United States	Community Howard Regional Hospital	Kokomo	Indiana
United States	St. Anthony Hospital	Lakewood	Colorado
United States	Saint Luke's Cancer Institute, Liberty	Liberty	Missouri
United States	Littleton Cancer Center	Littleton	Colorado
United States	Longmont Cancer Center	Longmont	Colorado
United States	Avista Cancer Center	Louisville	Colorado
United States	Avera Cancer Institute- Marshall	Marshall	Minnesota
United States	Columbia St. Mary's	Mequon	Wisconsin
United States	Columbia St. Mary's	Milwaukee	Wisconsin
United States	Trinity Hospital Cancer Care Center	Minot	North Dakota
United States	Providence St. Patrick Hospital Montana Cancer Center	Missoula	Montana
United States	Avera Cancer Institute	Mitchell	South Dakota
United States	Trinity Medical Center	Moline	Illinois
United States	Tulane University	New Orleans	Louisiana
United States	Faith Regional Health Services, Carson Cancer Center	Norfolk	Nebraska
United States	Great Plains Regional Medical Center	North Platte	Nebraska
United States	Avera St. Anthony's Hospital	O'Neill	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Nebraska Methodist Health System	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital FISH	Orange City	Florida
United States	Ascension Mercy Hospital	Oshkosh	Wisconsin
United States	Saint Luke's Cancer Instititue - South	Overland Park	Kansas
United States	Florida Hospital Flagler	Palm Coast	Florida
United States	Parker Adventist Hospital	Parker	Colorado
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Breast Care Specialists of Maine	Portland	Maine
United States	St. Mary Corwin Medical Center	Pueblo	Colorado
United States	Wheaton Franciscan Healthcare, All Saints	Racine	Wisconsin
United States	Northwest Hospital	Randallstown	Maryland
United States	Rutland Regional Medical Center	Rutland	Vermont
United States	Heartland Regional Medical Center dba Mosaic Life Care	Saint Joseph	Missouri
United States	Regional West Health Services	Scottsbluff	Nebraska
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sanford Health	Sioux Falls	South Dakota
United States	Abben Cancer Center	Spencer	Iowa
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Faxton St. Luke's Healthcare, Mohawk Valley	Utica	New York
United States	Covenant Medical Center, Inc	Waterloo	Iowa
United States	Wheaton Franciscan Healthcare, Wauwatosa Cancer Care	Wauwatosa	Wisconsin
United States	St. Anthony North Cancer Center	Westminster	Colorado
United States	William E Kahlert Regional Cancer Center	Westminster	Maryland
United States	Avera Cancer Center Yankton	Yankton	South Dakota
United States	Avera Sacred Heart Hospital	Yankton	South Dakota
United States	Yankton Medical Clinic	Yankton	South Dakota
United States	Rush-Copley Healthcare Center	Yorkville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collection and banking of blood, DNA, and urine samples for future analysis that will be proposed in future studies	This is a registry with biobank and accrual will continue indefinitely	50 years
Primary	Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC)	This is a registry that will continue to accrue patients indefinitely	50 years
Secondary	Procurement and banking of excess biological material for future analysis	This is a registry and biobank and will continue to accrue indefinitely	50 years

External Links

•   icare2 website