Integrated Cancer Repository for Cancer Research (iCaRe2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02012699|
Recruitment Status : Recruiting
First Posted : December 16, 2013
Last Update Posted : May 9, 2017
|Condition or disease|
|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|
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]|
|Estimated Enrollment :||9999 participants|
|Target Follow-Up Duration:||80 Years|
|Official Title:||Integrated Cancer Repository for Cancer Research|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2099|
|Estimated Study Completion Date :||December 2099|
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012699
|Contact: Whitney Goldner, MDemail@example.com|
|Contact: Alice Kueh, MSfirstname.lastname@example.org|
Show 70 Study Locations
|Principal Investigator:||Whitney Goldner, MD||University of Nebraska|