Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study
18 Years
N/A
Both
Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Patients meeting the following criteria:
- Diagnosis of metastatic carcinoma
- Must be enrolled in 1 of the following surgical protocols:
- NCI-99-C-0123
- NCI-00-C-0069
- NCI-03-C-0085
- NCI-03-C-0212
- Healthy control participant* meeting the following criteria:
- No anemia or thrombocytopenia
- No history of venous thromboembolism (deep vein thrombosis, pulmonary emboli)
- No history of coronary artery disease or stroke
- No chronic inflammatory disease
- No diabetes mellitus
- Have not smoked tobacco within the past 6 months NOTE: * Selected on the basis
of gender and age to match the patients as they are accrued
PATIENT CHARACTERISTICS:
- No symptomatic infections or other acute illness within the past 14 days
PRIOR CONCURRENT THERAPY:
- At least 3 days since prior drugs known to inhibit platelet function
- At least 7 days since prior acetylsalicylic acid
- No concurrent estrogen contraceptives or hormone replacement therapy
- No concurrent anticoagulants
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Incidence of hypercoagulability
Safety Issue:
No
Principal Investigator
McDonald K. Horne, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000440092
NCT ID:
NCT00096590
Start Date:
November 2004
Completion Date:
Related Keywords:
- Thromboembolism
- Unspecified Adult Solid Tumor, Protocol Specific
- thromboembolism
- unspecified adult solid tumor, protocol specific
- Thromboembolism
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
