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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

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.

Condition or disease Intervention/treatment
Neoplasms, Connective and Soft Tissue Bone Neoplasms Other: Observation

Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
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.

Information from the National Library of Medicine

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): NCT02677961


Contacts
Contact: Audra Phillips 614-293-6171 Audra.Phillips@osumc.edu
Contact: David A Liebner, MD (614) 293-2886 David.Liebner@osumc.edu

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Audra Phillips    614-293-6171    Audra.Phillips@osumc.edu   
Contact: David A Liebner, MD    (614) 293-2886    David.Liebner@osumc.edu   
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: David A Liebner, MD Ohio State University

Additional Information:
Responsible Party: David Liebner, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02677961     History of Changes
Other Study ID Numbers: OSU-14242
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by David Liebner, Ohio State University Comprehensive Cancer Center:
sarcoma
registry

Additional relevant MeSH terms:
Neoplasms
Bone Neoplasms
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Histologic Type