Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00096590

Purpose

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.

Condition	Intervention
Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific	Other: coagulation study Other: immunoenzyme technique Other: laboratory biomarker analysis Other: physiologic testing Procedure: study of high risk factors

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

Resource links provided by NLM:

Genetics Home Reference related topics: factor V Leiden thrombophilia prothrombin thrombophilia

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of hypercoagulability [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	November 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096590

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

McDonald K. Horne, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	CDR0000440092, NCI-05-CC-0033
Study First Received:	November 11, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00096590 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

thromboembolism
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on November 30, 2009