Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

Completed

• Conditions: Thromboembolism; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00096590
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery.

PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery.

Detailed Description

OBJECTIVES:

Primary

* Determine whether whole blood thrombin generation assay (WBTGA) detects hypercoagulability in patients with metastatic carcinoma compared with a healthy control group.

* Determine whether results of the WBTGA will change as a result of major surgery performed on patients with metastatic carcinoma.

* Establish a reference interval for the WBTGA using healthy controls.

Secondary

* Compare a battery of plasma components known to affect or reflect coagulant or fibrinolytic reactions in patients with metastatic carcinoma vs healthy controls.

* Establish reference intervals for this battery of tests using healthy controls.

* Determine how major surgery in cancer patients affects this battery of factors.

* Identify changes in these factors that correlate with changes in the WBTGA.

* Compare the results of WBTGA tests in patients who develop venous thromboembolism (VTE) with those who do not.

OUTLINE: This is a pilot study.

Blood samples of patients are collected on day -7 and day 1 after surgery.

Blood samples of healthy controls are collected once.

After collection, blood samples are analyzed for hypercoagulability by whole blood thrombin generation assay. Routine blood tests are performed, as are immunoenzyme techniques for antigenic tissue plasminogen activator and its inhibitor, thrombin-antithrombin complexes, tissue factor, factor VIIa, D-dimer, and glycocalicin.

PROJECTED ACCRUAL: A total of 30 patients and 30 healthy controls will be accrued for this study.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-11
• Study First Submitted QC: 2004-11-11
• Study First Posted: 2004-11-12
• Status Verified: 2007-06
• Last Update Submitted: 2009-05-09
• Last Update Posted: 2009-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hypercoagulability

Secondary Outcome Measures

Name	Time	Method
Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States