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Cancer Research Repository for Individuals With Cancer Diagnosis, High Risk Individuals, and Individuals With No History of Cancer (Control) (iCaRe2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 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: November 14, 2016
Last verified: November 2016
  Purpose
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.

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

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: 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. 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:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 110 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
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.
  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

  Show 54 Study Locations
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Whitney Goldner, MD University of Nebraska
  More Information

Additional Information:
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: November 14, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Pancreatic Neoplasms
Rectal Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Mesothelioma
Thyroid Neoplasms
Endometrial Neoplasms
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Anus Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Salivary Gland Neoplasms
Skin Neoplasms
Intestinal Neoplasms
Mouth Neoplasms
Adenomatous Polyposis Coli
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Urethral Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Vaginal Neoplasms
Breast Neoplasms
Ureteral Neoplasms
Testicular Neoplasms

ClinicalTrials.gov processed this record on December 02, 2016