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Integrated Cancer Repository for Cancer Research (iCaRe2)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Whitney Goldner, MD, 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: May 5, 2017
Last verified: May 2017
  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 Whitney Goldner, MD, 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 ]
    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 ]
    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 ]
    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.


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)
Sexes Eligible for Study:   All
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 70 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: May 5, 2017
Individual Participant Data  
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Whitney Goldner, MD, 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
Stomach Neoplasms
Rectal Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Mesothelioma
Thyroid Neoplasms
Endometrial Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Skin Neoplasms
Salivary Gland Neoplasms
Anus Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Urethral Neoplasms
Nasopharyngeal Neoplasms
Oropharyngeal Neoplasms
Vaginal Neoplasms
Laryngeal Neoplasms
Adenomatous Polyposis Coli
Mouth Neoplasms
Intestinal Neoplasms
Hypopharyngeal Neoplasms
Testicular Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Penile Neoplasms

ClinicalTrials.gov processed this record on June 23, 2017