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

NCT ID: NCT02677961

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Neoplasms, Connective and Soft Tissue Bone Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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David Liebner, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Liebner, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Fetzer

Role: CONTACT

David A Liebner, MD

Role: CONTACT

(614) 293-2886

Facility Contacts

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Erin Fetzer

Role: primary

David A Liebner, MD

Role: backup

(614) 293-2886

Related Links

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Other Identifiers

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OSU-14242

Identifier Type: -

Identifier Source: org_study_id

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