Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096590
Status:
COMPLETED
Last Update Posted:
2009-05-12
First Post:
2004-11-11
Brief Title:
Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-05-CC-0033 | None | None | None |