Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at Risk for Recurrence of Venous Thromboembolism (REMARK)
The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Compliance to medication will be measured by review of the patient medication diary.
Biospecimen Retention: Samples With DNA
Serum specimens Optional DNA banking
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
All cancer patients with a diagnosed acute symptomatic VTE episode.
Therapeutic failure in cancer patients at high risk for recurrence of Venous thromboembolism (VTE) may be as high as 20% and the risk of death from a recurrent episode of pulmonary embolism is at least 8%. Studies that have used pro-coagulant and thrombin generation markers support the notion that cancer is associated with a hypercoagulability state and that intensified doses of anticoagulation may be necessary to suppress this state. Thus, it may be possible that by using these tests, we would identify the patients that do not respond to standard doses of anticoagulation. To date, only few small studies have evaluated the use of pro-coagulant markers in cancer patients but this data is promising. Our study will measure pro-coagulant markers in cancer patients at risk for VTE recurrence to determine if there is a relationship between the changes in the levels of pro-coagulant markers and VTE recurrence while taking anticoagulation with low-molecular weight-heparin (LMWH). The evaluation of the pro-coagulant markers may enable new treatment strategies in cancer patients who fail their initial treatment. Patients will be stratified by a risk model developed by our group and will be validate with this study. This new approach has the potential to improve the recovery of patients, to reduce death and disability due to clots in the veins of legs or arms and/or lungs.
Please refer to this study by its ClinicalTrials.gov identifier: 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|