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| Tracking Information | |||||
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| First Received Date ICMJE | November 11, 2004 | ||||
| Last Updated Date | May 9, 2009 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Incidence of hypercoagulability [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00096590 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery | ||||
| Official Title ICMJE | Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study | ||||
| 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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 Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00096590 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000440092, NCI-05-CC-0033 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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