NCT01132833CompletedNot Applicable
Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
UNC Lineberger Comprehensive Cancer Center1 site in 1 country18 target enrollmentStarted: December 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Levels of circulating tissue factor (TF)
Study Overview
Brief Summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.
PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.
Detailed Description
OBJECTIVES:
Primary
- To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.
Secondary
- To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin [TAT] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
- To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Levels of circulating tissue factor (TF)
Time Frame: 5 years
Secondary Outcomes
- Correlation of TF with markers of coagulation activation and endothelial activation(5 years)
- Incidence of venous thromboembolism(5 years)
- Alteration in coagulation parameters(5 years)
Investigators
Study Sites (1)
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