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Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096590
Recruitment Status : Completed
First Posted : November 12, 2004
Last Update Posted : May 12, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific Other: coagulation study Other: immunoenzyme technique Other: laboratory biomarker analysis Other: physiologic testing Procedure: study of high risk factors

Detailed Description:



  • 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.


  • 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Incidence of hypercoagulability

Secondary Outcome Measures :
  1. Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


  • No symptomatic infections or other acute illness within the past 14 days


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096590

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: McDonald K. Horne, MD National Cancer Institute (NCI)
Publications of Results:
Layout table for additonal information Identifier: NCT00096590    
Obsolete Identifiers: NCT00464360
Other Study ID Numbers: CDR0000440092
First Posted: November 12, 2004    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: June 2007
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases