Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at Risk for Recurrence of Venous Thromboembolism (REMARK)
|ClinicalTrials.gov Identifier: NCT01602445|
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : May 11, 2017
|Condition or disease|
|Venous Thromboembolism Deep-Vein Thrombosis Pulmonary Embolism Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Analysis of Pro-coagulant and Thrombin-generation Markers for the Prediction of Therapeutic Failure in Cancer Patients at Risk for Recurrence of Venous Thromboembolism: A Pilot Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
All cancer patients with a diagnosed acute symptomatic VTE episode.
- Relative changes on biochemical markers [ Time Frame: at initiation of anticoagulation (baseline); at 7-14 days; 21-35 days; 37- 44 days; 83-97 days; and 173-187 days after initiation of anticoagulation. ]
The following pro-coagulant and thrombin-generation markers will be measured:
- Prothrombin fragments F1+2;
- thrombin-antithrombin (TAT)
- Soluble P-selectin.
For each patient, we will calculate baseline values and the relative changes (delta) of procoagulant and thrombin generation markers. The relative changes (delta) will be defined by the percentage of change in the marker at each visit relative to baseline measurement.
- Rates of treatment failure [ Time Frame: 6 months ]This outcome will be measured by the proportion of cancer patients who might develop recurrent VTE while on 6-month treatment with anticoagulation within the time-frame of the study.
- Correlation between treatment failure and markers [ Time Frame: 6 months after treatment failure ]This outcome will be assessed by determining the best cutoff for each marker that would correctly classify success or failure to anticoagulation treatment
- Compliance to anticoagulation treatment [ Time Frame: 6 months ]Compliance to medication will be measured by review of the patient medication diary.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602445
|Canada, Nova Scotia|
|Capital Health District Authority|
|Halifax, Nova Scotia, Canada|
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 0A6|
|London Health Science Centre|
|London, Ontario, Canada, N6A 5W9|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Montreal, Quebec, Canada|
|Principal Investigator:||Philip S Wells, MD||Ottawa Hospital Research Institute|