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An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry

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ClinicalTrials.gov Identifier: NCT02677961
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
David Liebner, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date February 5, 2016
First Posted Date February 9, 2016
Last Update Posted Date June 13, 2018
Actual Study Start Date June 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2016)
Overall Survival [ Time Frame: 5 Years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02677961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Official Title An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Brief Summary Translational studies in cancer research can be impeded by the lack of high-quality clinical data that can be correlated with research questions. This is particularly true in the case of rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue tumors.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with a diagnosis of bone or soft-tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.)
Condition
  • Neoplasms, Connective and Soft Tissue
  • Bone Neoplasms
Intervention Other: Observation
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 12, 2018)
400
Original Estimated Enrollment
 (submitted: February 5, 2016)
150
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.)
  • Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate.

Exclusion Criteria:

  • Prisoners are excluded from participation in the Registry.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Audra Phillips 614-293-6171 Audra.Phillips@osumc.edu
Contact: David A Liebner, MD (614) 293-2886 David.Liebner@osumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02677961
Other Study ID Numbers OSU-14242
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Liebner, Ohio State University Comprehensive Cancer Center
Study Sponsor Ohio State University Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: David A Liebner, MD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date June 2018