Integrated Cancer Repository for Cancer Research

Learn more about:
Related Clinical Trial
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance Integrated Cancer Repository for Cancer Research Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer Primary Organoid Models and Combined Nucleic Acids Therapeutics for Anti-HPV Treatments Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer Internet-based System for Cancer Patients to Self-report Toxicity Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy Lymphoscintigraphy in Patients With Vaginal Cancer Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer Pelvic Fractures and Radiation Therapy for Cervical Cancer Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

Brief Title

Integrated Cancer Repository for Cancer Research

Official Title

Integrated Cancer Repository for Cancer Research

Brief Summary

      The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela
      Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal
      data and biospecimens on consented adult cancer patients, high-risk individuals, and normal
      controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a
      significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances
      comprehensive studies of risk factors of cancer development and progression and enables the
      design of novel strategies for prevention, screening, early detection and personalized
      treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early
      detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and
      population studies.
    

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),
      Plasma Cell Dyscrasias Collaborative Registry (PDCR), Neuroendocrine Collaborative Registry
      (NETR), 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]


Primary Outcome

Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC)

Secondary Outcome

 Procurement and banking of excess biological material for future analysis

Condition

Pancreatic Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

999999

Start Date

November 2013

Completion Date

December 2099

Primary Completion Date

December 2099

Eligibility 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.
      

Gender

All

Ages

19 Years - 110 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Whitney Goldner, MD, 402-559-3579, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02012699

Organization ID

253-13


Responsible Party

Principal Investigator

Study Sponsor

University of Nebraska


Study Sponsor

Whitney Goldner, MD, Principal Investigator, University of Nebraska


Verification Date

November 2020