Tumor Thrombus
Conditions
Brief summary
The purpose of this study is to conduct a retrospective review of oncology patients with a diagnosis of any solid tumor and lymphoma to identify a cohort with radiographically reported tumor thrombus or tumor compression of vasculature. Clinical and radiographic data will be collected on this cohort to understand the incidence and management of tumor thrombus or vascular compression, as well as relevant clinical outcomes, including bleeding, thrombus extension or embolism, and mortality.
Detailed description
Identify and characterize (by clinical, demographic, and radiographic data) pediatric and AYA solid tumor oncology patients with radiographic evidence of tumor thrombus. Assess clinical outcomes (bleeding, thrombus resolution, thrombus extension or embolization, and mortality related to anticoagulation treatment vs non-treatment of identified tumor thrombus. Identify and characterize pediatric and AYA solid tumor patients with a tumor compressing a vascular structure without thrombosis, as identified by review of radiographic reports.
Interventions
None listed
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 40 Years
Healthy volunteers
No
Inclusion criteria
All Cincinnati Children's Hospital Medical Center (CCHMC) Oncology patients in the cancer registries (ACCRN07 CCHMC IRB #2008-1609 and the COG Registry CCHMC IRB # 2019-0616) identified as having a solid tumor and lymphoma (including osteosarcoma, Ewing sarcoma, Wilms tumor, hepatoblastoma, neuroblastoma, Hodgkin's and non-Hodgkin's lymphoma) diagnosis, and who, on review of radiographic study reports, have mention of tumor thrombus or vascular compression since January 01, 2010 - January 01, 2026, between the ages of 0 and 40 years old.
Exclusion criteria
Cancer diagnosis other than a lymphoma or solid tumor Absence of tumor thrombus or vascular compression mentioned in radiographic reports stored at CCHMC (EPIC © 2020 Epic Systems Corporation). Lack of medical records available at CCHMC for review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anticoagulation or vascular intervention | Baseline through study completion, an average of 1 year | Documentation in medical record of patient being placed on prophylactic or therapeutic anticoagulation or requiring therapeutic intervention (such as thrombectomy graft, stent, thrombolysis, or venoplasty) |
| Clinical bleeding event | Baseline through study completion, an average of 1 year | Major and clinically relevant non-major bleeding per ISTH definition |
| Thrombus extension | Baseline through study completion, an average of 1 year | Documented episode of thrombus extension or embolism, or bland thrombus formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage of oncologic disease at diagnosis | Baseline through study completion, an average of 1 year | As indicated by local vs metastatic disease spread |
| New vs relapsed oncologic disease | Baseline through study completion, an average of 1 year | Patient presenting with a new diagnosis vs relapsed disease when tumor thrombus identified |
| Disease status at last follow up | Baseline through study completion, an average of 1 year | a. Patient alive with no evidence of disease, alive with disease, dead of disease, died of other causes, lost to follow up |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLindsay Haacker, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed