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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02677961
Other study ID # OSU-14242
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2015
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact Erin Fetzer
Email erin.fetzer@osumc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES: I. To create a secure EHR-based registry to allow for the prospective collection of clinical and research data in a collection of rare diseases (bone and soft-tissue tumors). II. To facilitate the identification and validation of clinical and molecular features that may be associated with prognosis and/or response to therapy in (subtypes) of bone and soft-tissue tumors. III. To pilot a mechanism that will facilitate future collaboration between institutions for research and analysis of bone and soft-tissue tumors. IV. To standardize biospecimen collection for correlative biomarker analysis for patients undergoing treatment and surveillance for bone and soft tissue tumors at Ohio State University. OUTLINE: This is an observational study. Patients complete quality of life questionnaires and their medical records are reviewed. Patients may also undergo collection of blood samples for up to 2 years, unless otherwise specified in the protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation


Locations

Country Name City State
United States Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival 5 Years
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