Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

NCT00096590 | Completed

• 2 other identifiers: CDR0000440092NCI-05-CC-0033
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

thromboembolism; unspecified adult solid tumor, protocol specific

Outcome Measures

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

Interventions

coagulation study OTHER

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

physiologic testing OTHER

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 17570509 RESULT

MeSH Terms

Conditions

Thromboembolism

Interventions

Bleeding Time; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Platelet Function Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• McDonald K. Horne, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 11, 2004
• First Posted: November 12, 2004
• Study Start: November 1, 2004
• Last Updated: May 12, 2009

Record last verified: 2007-06

Locations

US (1)