Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096590
• Other study ID #: CDR0000440092
• Secondary ID: NCI-05-CC-0033
• Status: Completed
• Phase: N/A
• First received: November 11, 2004
• Last updated: May 9, 2009
• Start date: November 2004

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00464360

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Thromboembolism
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• coagulation study

• immunoenzyme technique

• laboratory biomarker analysis

• physiologic testing

Procedure:
• study of high risk factors

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypercoagulability			No
Secondary	Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not			No