Integrated Cancer Repository for Cancer Research (iCaRe2)

February 29, 2024 updated by: University of Nebraska
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.

Study Overview

Status

Recruiting

Conditions

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 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.

Study Type

Observational

Enrollment (Estimated)

999999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michelle M Desler, MS
  • Phone Number: 402-559-8885
  • Email: mdesler@unmc.edu

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Completed
        • Penrose Cancer Center
      • Denver, Colorado, United States, 80210
        • Completed
        • Porter Adventist Hospital
      • Durango, Colorado, United States, 81301
        • Completed
        • Mercy Regional Medical Center
      • Lakewood, Colorado, United States, 80228
        • Completed
        • St. Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Completed
        • Littleton Cancer Center
      • Longmont, Colorado, United States, 80501
        • Completed
        • Longmont Cancer Center
      • Louisville, Colorado, United States, 80027
        • Completed
        • Avista Cancer Center
      • Parker, Colorado, United States, 80138
        • Completed
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Completed
        • St. Mary Corwin Medical Center
      • Westminster, Colorado, United States, 80228
        • Completed
        • St. Anthony North Cancer Center
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Recruiting
        • Bristol Health Beekley
        • Contact:
        • Principal Investigator:
          • Noelle Beauchemin, MD
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Florida Hospital Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Erik Harris, MD
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Florida Hospital DeLand
        • Contact:
        • Principal Investigator:
          • Erik Harris, MD
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Florida Hospital FISH
        • Contact:
        • Principal Investigator:
          • Erik Harris, MD
      • Palm Coast, Florida, United States, 32164
        • Recruiting
        • Florida Hospital Flagler
        • Contact:
        • Principal Investigator:
          • Erik Harris, MD
      • Tallahassee, Florida, United States, 32308
    • Illinois
      • Aurora, Illinois, United States, 60504
      • Moline, Illinois, United States, 61265
        • Completed
        • Trinity Medical Center
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Joseph T Meschi, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center
        • Contact:
          • Neil Sharma, MD
        • Contact:
          • Breck Hunnicutt, RN BSN CCRC
          • Phone Number: 260-266-9168
      • Indianapolis, Indiana, United States, 46227
        • Recruiting
        • Community Cancer Center South
        • Contact:
        • Principal Investigator:
          • Anuj Agarwala, MD
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Community Cancer Center North
        • Contact:
        • Principal Investigator:
          • Anuj Agarwala, MD
      • Indianapolis, Indiana, United States, 46219
      • Kokomo, Indiana, United States, 46902
        • Recruiting
        • Community Howard Regional Hospital
        • Contact:
        • Contact:
          • Anuj Agarwala, MD
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Methodist Jennie Edmundson Hospital
        • Contact:
          • Michael Zlomke, MD
          • Phone Number: 712-396-4117
        • Contact:
      • Davenport, Iowa, United States, 52804
        • Completed
        • Genesis Medical Center
      • Spencer, Iowa, United States, 51301
        • Completed
        • Abben Cancer Center
      • Waterloo, Iowa, United States, 50702
        • Recruiting
        • Covenant Medical Center, Inc
        • Principal Investigator:
          • Mukund Nadipuram, MD
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Recruiting
        • Saint Luke's Cancer Instititue - South
        • Contact:
        • Principal Investigator:
          • Addison Tolentino, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Completed
        • Tulane University
    • Maine
      • Portland, Maine, United States, 04102
        • Completed
        • Breast Care Specialists of Maine
    • Maryland
      • Randallstown, Maryland, United States, 21133
        • Recruiting
        • Northwest Hospital
        • Contact:
        • Principal Investigator:
          • Qiwei Gai, MD
      • Westminster, Maryland, United States, 21157
        • Recruiting
        • William E Kahlert Regional Cancer Center
        • Contact:
        • Sub-Investigator:
          • Johanna DiMento, MD
    • Massachusetts
      • Holyoke, Massachusetts, United States, 01040
        • Recruiting
        • Holyoke Medical Center
        • Contact:
        • Principal Investigator:
          • Zubeena Mateen, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Completed
        • University of Michigan Health System
    • Minnesota
      • Aitkin, Minnesota, United States, 56431
      • Brainerd, Minnesota, United States, 56401
      • Duluth, Minnesota, United States, 55805
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • St. Luke's Hospital of Duluth
        • Principal Investigator:
          • Anne Silva-Benedict, MD
        • Contact:
      • Fergus Falls, Minnesota, United States, 56537
      • Marshall, Minnesota, United States, 56258
        • Completed
        • Avera Cancer Institute- Marshall
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Completed
        • Mercy Hospital - Joplin
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute
        • Contact:
        • Principal Investigator:
          • Addison Tolentino, MD
      • Kansas City, Missouri, United States, 64086
        • Recruiting
        • Saint Luke's Cancer Institute, East
        • Contact:
        • Principal Investigator:
          • Addison Tolentino, MD
      • Kansas City, Missouri, United States, 64118
        • Recruiting
        • Saint Luke's Cancer Institute, Kansas City North
        • Contact:
        • Principal Investigator:
          • Addison Tolentino, MD
      • Liberty, Missouri, United States, 64068
        • Recruiting
        • Saint Luke's Cancer Institute, Liberty
        • Contact:
        • Principal Investigator:
          • Addison Tolentino, MD
      • Saint Joseph, Missouri, United States, 64507
        • Recruiting
        • Heartland Regional Medical Center dba Mosaic Life Care
        • Principal Investigator:
          • Juliet Gyamfua Appiah, MD
        • Contact:
    • Montana
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • Justin Thomas, MD
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health
        • Contact:
          • Melissa Lundbeck Kaptanian, MD
          • Phone Number: 406-752-8669
          • Email: mhulvat@krmc.org
        • Contact:
      • Missoula, Montana, United States, 59802
        • Completed
        • Providence St. Patrick Hospital Montana Cancer Center
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Recruiting
        • Mary Lanning Healthcare, Morrison Cancer Center
        • Contact:
      • Norfolk, Nebraska, United States, 68701
        • Recruiting
        • Faith Regional Health Services, Carson Cancer Center
        • Contact:
        • Sub-Investigator:
          • Rahib C Fahed, MD
        • Sub-Investigator:
          • Irena Popa, MD
      • North Platte, Nebraska, United States, 69101
        • Recruiting
        • Great Plains Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Irfan Vaziri, MD
      • O'Neill, Nebraska, United States, 68763
        • Completed
        • Avera St. Anthony's Hospital
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Whitney Goldner, MD
          • Phone Number: 402-559-3579
        • Contact:
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Methodist Estabrook Cancer Center
        • Contact:
          • Russell Smith, MD
        • Contact:
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Health System
        • Contact:
        • Principal Investigator:
          • Aru Panwar, MD
      • Scottsbluff, Nebraska, United States, 69361
        • Completed
        • Regional West Health Services
    • New York
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • C.R. Wood Cancer Center, Glens Falls Hospital
        • Contact:
        • Contact:
          • Aqeel Gillani, MD
          • Phone Number: 518-926-6701
        • Sub-Investigator:
          • Aqeel Gillani, MD
      • Utica, New York, United States, 13501
        • Suspended
        • Faxton St. Luke's Healthcare, Mohawk Valley
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Cape Fear Valley Health System
        • Contact:
          • Kenneth Manning, MD
        • Contact:
    • North Dakota
    • Ohio
      • Alliance, Ohio, United States, 44601
        • Recruiting
        • Aultman Alliance Community Hospital
        • Contact:
        • Principal Investigator:
          • Shruti Trehan, MD
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Contact:
        • Principal Investigator:
          • Shruti Trehan, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15323
        • Completed
        • University of Pittsburgh
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Completed
        • Avera Medical Group Oncology and Hematology Aberdeen
      • Mitchell, South Dakota, United States, 57301
        • Completed
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Completed
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health
        • Contact:
          • William Spanos, MD
          • Phone Number: 605-328-8200
        • Contact:
      • Yankton, South Dakota, United States, 57078
        • Completed
        • Avera Cancer Center Yankton
      • Yankton, South Dakota, United States, 57078
        • Completed
        • Avera Sacred Heart Hospital
      • Yankton, South Dakota, United States, 57078
        • Completed
        • Yankton Medical Clinic
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Recruiting
        • Rutland Regional Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Allan D Eisemann, MD
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Recruiting
        • Mary Washington Hospital
        • Contact:
        • Principal Investigator:
          • Darlene Blanchard, MD
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • Completed
        • Ascension St. Elizabeth Hospital
      • Brookfield, Wisconsin, United States, 53045
        • Completed
        • Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital
      • Franklin, Wisconsin, United States, 53132
        • Completed
        • Wheaton Franciscan Healthcare, Reiman Cancer Care
      • Green Bay, Wisconsin, United States, 54305
        • Recruiting
        • Bellin Memorial Hospital
        • Principal Investigator:
          • Hassan Tahsildar, MD
        • Contact:
        • Contact:
      • Mequon, Wisconsin, United States, 53097
        • Completed
        • Columbia St. Mary's
      • Milwaukee, Wisconsin, United States, 53211
        • Completed
        • Columbia St. Mary's
      • Oshkosh, Wisconsin, United States, 54904
        • Completed
        • Ascension Mercy Hospital
      • Racine, Wisconsin, United States, 53405
        • Completed
        • Wheaton Franciscan Healthcare, All Saints
      • Wauwatosa, Wisconsin, United States, 53226
        • Completed
        • Wheaton Franciscan Healthcare, Wauwatosa Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any individual who meets the eligibility criteria will be invited to participate in iCaRe2.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procurement and banking of excess biological material for future analysis
Time Frame: 50 years
This is a registry and biobank and will continue to accrue indefinitely
50 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection and banking of blood, DNA, and urine samples for future analysis that will be proposed in future studies
Time Frame: 50 years
This is a registry with biobank and accrual will continue indefinitely
50 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Ken Cowan, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Estimated)

December 1, 2099

Study Completion (Estimated)

December 1, 2099

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimated)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0253-13-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data and/or specimen request have to be made to the Principal Investigator of the center and follow the Human Subject Protection guidelines and policy.

IPD Sharing Time Frame

as long as the registry is open

IPD Sharing Access Criteria

Institutional Review Board approval to analyze data for separate study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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