Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

National Cancer Institute (NCI)

Status: Completed

Conditions: Thromboembolism; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: immunoenzyme technique; Other: physiologic testing; Other: laboratory biomarker analysis; Procedure: study of high risk factors; Other: coagulation study

Study type: Observational

Funder types: NIH

Identifiers

NCT00096590

NCI-05-CC-0033

CDR0000440092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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