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Integrated Cancer Repository for Cancer Research (iCaRe2)

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ClinicalTrials.gov Identifier: NCT02012699
Recruitment Status : Recruiting
First Posted : December 16, 2013
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Whitney Goldner, MD, University of Nebraska

Tracking Information
First Submitted Date December 2, 2013
First Posted Date December 16, 2013
Last Update Posted Date November 5, 2018
Actual Study Start Date November 2013
Estimated Primary Completion Date December 2099   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02012699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2013)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2013)
Collection and banking of blood, DNA, and urine samples for future analysis that will be proposed in future IRB submissions [ Time Frame: 25 years ]
This is a registry with biobank and accrual will continue indefinitely
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Integrated Cancer Repository for Cancer Research
Official Title Integrated Cancer Repository for Cancer Research
Brief Summary The objectives of this project at UNMC and other IRB approved sites is to implement and maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core support services for future IRB approved multidisciplinary research on cancer and other chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well as internal and external research collaborators from different participating institutions/centers.
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) 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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 80 Years
Biospecimen Retention:   Samples With DNA
Description:

Questionnaire: baseline, follow up and annually. Blood: obtain 30 ml of blood at enrollment, annually and at recurrence. Urine: donate a urine sample at enrollment and follow up appointments. Access to leftover tissue: release a portion of leftover tissue collected and saved from surgery/biopsy.

Urine: obtain 1/4 cup of urine at enrollment date. Additional 1/4 cup of urine may be collected at follow up visits.

Tissue procurement and banking of excess biological materials. This includes but not limited to tumor tissue and/or metastatic cancer tissue and/or paraffin embedded tissue collected and saved from biopsy and/or surgery done in the past or future, from registry participants.

Sampling Method Non-Probability Sample
Study Population Any individual who meets the eligibility criteria will be invited to participate in iCaRe2.
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
  • Breastcancer
  • Leukemia
  • Melanoma
  • Sarcoma
  • Unknown Primary Tumor
  • Multiple Myeloma
  • Ovarian Cancer
  • Endometrial Cancer
  • Vaginal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2013)
9999
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2099
Estimated Primary Completion Date December 2099   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Whitney Goldner, MD 402-559-3579 wgoldner@unmc.edu
Contact: Michelle Desler, MS 402-559-8885 mdesler@unmc.edu
Listed Location Countries Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02012699
Other Study ID Numbers 253-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All data and/or specimen request have to be made to the PI of the center and follow the Human Subject Protection guidelines and policy.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: as long as the registry is open
Access Criteria: IRB approval to analyze data for separate study
Responsible Party Whitney Goldner, MD, University of Nebraska
Study Sponsor University of Nebraska
Collaborators Not Provided
Investigators
Principal Investigator: Whitney Goldner, MD University of Nebraska
PRS Account University of Nebraska
Verification Date November 2018