An EHR-Based Comprehensive Bone and Soft Tissue Tumor Registry
This study collects clinical data and blood samples from patients with bone or soft tissue tumor to create an electronic health record (EHR)-based clinical registry. Creating an EHR-based clinical registry, may improve clinical and research studies which may contribute to improved disease control rates and cures in bone and soft tissue tumors.
Inclusion Criteria
- BONE AND SOFT TISSUE REGISTRY
- Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor
- Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate
- BIOSPECIMEN COLLECTION SUBPROTOCOLS
- Patient must be undergoing treatment or surveillance for a diagnosis of bone or soft tissue tumor at the Ohio State University Comprehensive Cancer Center (OSUCCC)
- Patient must also be enrolled in the Total Cancer Care Protocol (TCCP)
- Subprotocol eligibility: * Cohort A High-dose doxorubicin/ifosfamide (HD-AIM) chemotherapy: Patients must be scheduled for treatment with systemic chemotherapy with the chemotherapy agents doxorubicin, ifosfamide, and mesna per standard institutional protocols for a diagnosis of bone or soft tissue tumor within 45 days of signing consent. A total of 30 individuals will be recruited to this cohort. This amendment is currently closed to additional accruals * Cohort B – Doxorubicin plus olaratumab chemotherapy: Patients must be scheduled for treatment with systemic chemotherapy with the chemotherapy agents doxorubicin and olaratumab per standard institutional protocols for a diagnosis of bone or soft tissue tumor within 45 days of signing consent. A total of 30 individuals will be recruited to this cohort. N.B. This cohort is currently closed to additional accruals as of this protocol amendment. Patients who are already enrolled in this cohort prior to this amendment may continue to be followed per the current protocol guidelines * Cohort C – Trabectedin chemotherapy: Patients must be scheduled for systemic treatment with the chemotherapy agent trabectedin per standard institutional protocols for a diagnosis of bone or soft tissue tumor within 45 days of signing consent. A total of 30 individuals will be recruited to this cohort. This amendment is currently closed to additional accruals * Cohort D – Surgical cohort: Patients must be scheduled for surgical resection of one or more sites of disease within 45 days of signing consent. Patients with metastatic disease are eligible. Patients who will be receiving adjuvant systemic therapy are also eligible. After patient enrollment, if it is determined that a surgery will no longer be curative, the patient will come off the cohort study. However, they may be enrolled in Cohort E if appropriate. A total of 100 patients will be recruited to this cohort * Cohort E – Locally advanced/metastatic disease on systemic therapy: All patients must have a diagnosis of locally advanced or metastatic sarcoma and be scheduled to initiate systemic therapy (chemotherapy, targeted therapy, immunotherapy) per standard institutional protocols within 45 days of signing consent. Patients of special interest include those who are receiving a CDK4/6 inhibitors or cancer immune checkpoint inhibitors, those with genetically complex sarcomas, and those with translocation-related sarcomas. A total of 100 patients will be recruited to this cohort
Additional locations may be listed on ClinicalTrials.gov for NCT02677961.
Locations matching your search criteria
United States
Ohio
Columbus
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorDavid Andrew Liebner
- Primary IDOSU-14242
- Secondary IDsNCI-2020-01422, 2014C0181
- ClinicalTrials.gov IDNCT02677961