Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 10:40 PM
Study NCT ID:
NCT02677961
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2016-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: