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Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study


N/A
18 Years
N/A
Not Enrolling
Both
Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific

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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 PikeBethesda, Maryland  20892