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CompletedNCT00096590Updated May 12, 2009

Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

An observational study in Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-12.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thromboembolism
  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • thromboembolism
  • unspecified adult solid tumor, protocol specific
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's planned enrollment of 60 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Enrollment
60 participants (estimated)

Interventions

  • Othercoagulation study
  • Otherimmunoenzyme technique
  • Otherlaboratory biomarker analysis
  • Otherphysiologic testing
  • Procedurestudy of high risk factors
06

What researchers measure

Primary outcomes

  1. Incidence of hypercoagulability

Secondary outcomes

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

07

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Horne MK 3rd, Merryman PK, Cullinane AM, Nghiem K, Alexander HR. The impact of major surgery on blood coagulation factors and thrombin generation. Am J Hematol. 2007 Sep;82(9):815-20. doi: 10.1002/ajh.20963. PubMed 17570509 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00096590
Lead sponsor
National Cancer Institute (NCI)
First posted
Nov 12, 2004
Start date
Nov 2004
Last update
May 12, 2009

Study contacts

McDonald K. Horne, MD
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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