Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

May 9, 2009 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of hypercoagulability

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: McDonald K. Horne, MD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

November 11, 2004

First Submitted That Met QC Criteria

November 11, 2004

First Posted (Estimate)

November 12, 2004

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 9, 2009

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000440092
  • NCI-05-CC-0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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