Cancer Research Repository for Individuals With Cancer Diagnosis and High Risk Individuals. (iCaRe2)

This study is currently recruiting participants.
Verified December 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Whitney Goldner, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02012699
First received: December 2, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The objectives of this project at UNMC are to consolidate existing and future disease specific registries with biospecimen bank to provide a resource that fosters and improves the efficiency of cancer-related research and facilitates collaborations among centers. The Integrated Cancer Repository for Cancer Research (iCaRe2) consists mainly of registry database and human biological material (HBM). The type of HBM to be stored include blood (and its derivatives), urine and tissue. The source of the HBM will be from voluntary blood draw, urine collection and UNMC Solid Tumor Bank (IRB#281-96).


Condition
Pancreatic Cancer
Thyroid Cancer
Lung Cancer
Esophageal Cancer
Thymus Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 80 Years
Official Title: Integrated Cancer Repository for Cancer Research

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

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) [ Time Frame: 25 years ] [ Designated as safety issue: No ]
    This is a registry that will continue to accrue patients indefinitely


Secondary Outcome Measures:
  • Procurement and banking of excess biological material for future analysis [ Time Frame: 25 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 25 years ] [ Designated as safety issue: No ]
    This is a registry with biobank and accrual will continue indefinitely


Biospecimen Retention:   Samples With DNA

Questionnaire: Patients fill out questionnaires at baseline, and potentially follow up questionnaires at 6 months and annually.

Blood: obtain 30 ml of blood at enrollment and an additional 30ml may be obtained biannually or at recurrence.

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. If subjects have tissue outside of UNMC, subjects will sign a release of information so tissue slides can be obtained.


Estimated Enrollment: 9999
Study Start Date: November 2013
Estimated Study Completion Date: December 2099
Estimated Primary Completion Date: December 2099 (Final data collection date for primary outcome measure)
Detailed Description:

Currently there are four active cancer registries under the umbrella of iCaRe2: the Pancreatic Cancer Collaborative Registry (PCCR), Thyroid Cancer and Tumor Collaborative Registry (TCCR), GenitoUrinary Cancer Registry (GUCaRe) and Thoracic Oncology Cancer Registry (TOCR). These Cancer Registries (CR) were established to unite participating centers with expertise in cancer epidemiology, genetics, biology, early detection and patient care to facilitate the rapid and uniform collection of critical information and biological samples to be used in developing prevention, detection and treatment strategies against cancer. Fred and Pamela Buffett Cancer Center also adopted the caTISSUE Suite (https://cabig.nci.nih.gov/tools/catissuesuite), a biorepository tool that has been developed under the NCI's cancer Biomedical Informatics Grid (caBIG®) umbrella. The Cancer Registry (CR) database is coupled with the biospecimen annotation database (caTISSUE) to manage activities associated with the biospecimen inventorying, tracking, and basic annotation. It provides quality assurance for all these activities and permits the users to track the collection, storage and distribution (derivation and aliquot) of specimens. This consolidated tissue bank will continue to collect and store comprehensive data on cancer patients, survivors and high-risk individuals. The tissue bank couples with the caTissue Suite for annotation and management of the biospecimen data to be collected. Consolidating all the registries into one tissue bank will foster and improve the efficiency of cancer-related research and facilitates collaborations among centers. The Sub-PI from each registry will remain the sole contact and will maintain responsibility of the conduct of each registry. PCCR - Dr. Aaron Sasson, TCCR - Dr.Whitney Goldner, GUCaRe - Dr.Jue Wang and TOCR - Dr.Karin Trujillo respectively.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults (male and female, age 19 and older) who have diagnosis of cancer and adults considered to be an "at risk individual for cancer", such as but not limited to a tumor, mass, nodules, family history of cancer, or suspicious clinical findings.

Criteria

Inclusion Criteria:

  1. All adults (male and female, age 19 and older) who have diagnosis of cancer;
  2. All adults considered to be an "at risk individual for cancer", such as but not limited to a tumor, mass, nodules, family history of cancer, or suspicious clinical findings.
  3. Able to provide informed consent.
  4. English speaking.

Exclusion Criteria:

  1. Individual younger than 19 years of age.
  2. Individual who is unable to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012699

Contacts
Contact: Whitney Goldner, MD 402-559-3579 wgoldner@unmc.edu
Contact: Alice Kueh, MS 402-559-8511 akueh@unmc.edu

Locations
United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Charles Wilcox, MD         
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Kristen Vogel, MS, CGC    847-570-1322      
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Anderson, MD    734-936-4775      
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Eric Jensen, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Whitney Goldner, MD    402-559-3579      
Contact: Kelly Treude    402-559-7308    ktreude@unmc.edu   
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Russell Smith, MD         
Contact: Kelly Treude, BS    402-559-7308    ktreude@unmc.edu   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15323
Contact: Randall Brand, MD    412-623-4124      
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: William Spanos, MD    605-328-8200      
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Charles Longo, MD    605-322-7600      
Italy
University of Genoa Recruiting
Genoa, Italy
Contact: Paola Ghiorzo, PhD    390103538949      
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Whitney Goldner, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Whitney Goldner, MD, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT02012699     History of Changes
Other Study ID Numbers: UNMC 253-13
Study First Received: December 2, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
Pancreatic Cancer
Thyroid Cancer
Lung Cancer
Esophageal cancer
Thymus cancer
Pancreatic tumor
Esophageal tumor
Thymus tumor
Thyroid Tumor
Lung Tumor
Thyroid Nodule

Additional relevant MeSH terms:
Thyroid Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Thymus Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Thyroid Diseases
Endocrine System Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Lung Diseases
Respiratory Tract Diseases
Pancreatic Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014