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

Bone Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02677961
• Other study ID #: OSU-14242
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Neoplasms
• Neoplasms, Connective and Soft Tissue
• Soft Tissue Neoplasms

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

External Links

•   The Jamesline