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Clinical Trials/NCT01132833
NCT01132833
Completed
Not Applicable

Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.

UNC Lineberger Comprehensive Cancer Center1 site in 1 country18 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Myeloma
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
18
Locations
1
Primary Endpoint
Levels of circulating tissue factor (TF)
Status
Completed
Last Updated
9 years ago

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. OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information. After completion of study, patients are followed up for 3 months.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
January 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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