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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 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 12, 2014
Last verified: December 2014
  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
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

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 seven registries/tissue bank developed under the umbrella of iCaRe2: the Pancreatic Cancer Collaborative Registry (PCCR), Thyroid Cancer and Tumor Collaborative Registry (TCCR), GenitoUrinary Cancer Collaborative Registry (GUCaRe), Thoracic Oncology Collaborative Registry (TOCR), Gastrointestinal and Abdominal Cancer Collaborative Registry (GACCaRe), Head and Neck Cancer Collaborative Registry (HNCCR), Central Nervous System Tumor Collaborative Registry (CTCR) for collaborative multi-center research. 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 PI from each registry will remain the sole contact and will maintain responsibility of the conduct of each registry. For the purpose of consolidation into one IRB application, each PI is being assigned as Sub-PI. Namely, PCCR - Dr.Aaron Sasson, TCCR - Dr. Whitney Goldner, GUCaRe - Dr. Chad LaGrange , TOCR - Dr.Karin Trujillo, GACCaRe- Dr. Jason Foster, HNCCR- Dr.

Russell Smith, CTCR- Dr. Nicole Shonka 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Indiana
Parkview Research Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Neil Sharma, MD         
Contact: Breck Hunnicutt, RN BSN CCRC    260-266-9168      
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
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Russell Smith, MD         
Contact: Kelly Treude, BS    402-559-7308    ktreude@unmc.edu   
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   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Peter Allen    212-639-8714      
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15323
Contact: Randall Brand, MD    412-623-4124      
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Charles Longo, MD    605-322-7600      
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: William Spanos, MD    605-328-8200      
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
Obsolete Identifiers: NCT00693368
Other Study ID Numbers: UNMC 253-13
Study First Received: December 2, 2013
Last Updated: December 12, 2014
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
Thyroid Nodule
Lung Tumor

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Esophageal Neoplasms
Pancreatic Neoplasms
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Pancreatic Diseases

ClinicalTrials.gov processed this record on March 01, 2015