NCT02552381|Completed
Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH
FICT
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FICT
Sponsor study identifier
observational
389
1 country
1
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 20, 2019
Actual (reported)Study Completion
December 20, 2019
Actual (reported)The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 13, 2015
Actual (reported)September 17, 2015
Actual (reported)December 20, 2019
Actual (reported)December 20, 2019
Actual (reported)Dynamic evolution of the optical density delta (ODD)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay. Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months
Clotting time (s)
36 Months
Fibrin formation time (s)
36 Months
Lysis time (s)
36 Months
Duration and level of the plateau (s)
36 Months
Patients without LMWH treatment. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays * Other markers activity : sFVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Patients with LMWH treatment at prophylactic dose at enrollment only. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays, * Anti-FXa activity measured at baseline and every month, * Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Patients with LMWH treatment at therapeutic dose. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays, * Anti-FXa activity measured at baseline and every month, * Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients from Internal Medicine Department, in a French Hospital
Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)
Colombes, 92701, France
Meyer G. [Looking for the best molecule. A short history of anticoagulants]. Rev Mal Respir. 2011 Oct;28(8):951-3. doi: 10.1016/j.rmr.2011.09.006. Epub 2011 Oct 15. No abstract available. French.
Campbell RA, Aleman M, Gray LD, Falvo MR, Wolberg AS. Flow profoundly influences fibrin network structure: implications for fibrin formation and clot stability in haemostasis. Thromb Haemost. 2010 Dec;104(6):1281-4. doi: 10.1160/TH10-07-0442. Epub 2010 Sep 30. No abstract available.
Frozen citrated Poor Platelets Plasma
Isabelle Mahe, MD, PhD
Université of Paris 7 - Paris Diderot
Geneviève Contant, PhD
Diagnostica Stago
389 participants (actual enrollment reported by the registry).
First Submitted
August 13, 2015
First Posted
September 17, 2015
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy
Contact the study team to confirm eligibility.
Wolberg AS, Gabriel DA, Hoffman M. Analyzing fibrin clot structure using a microplate reader. Blood Coagul Fibrinolysis. 2002 Sep;13(6):533-9. doi: 10.1097/00001721-200209000-00008.
Varin R, Mirshahi S, Mirshahi P, Kierzek G, Sebaoun D, Mishal Z, Vannier JP, Yvonne Borg J, Simoneau G, Soria C, Soria J. Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity. Thromb Haemost. 2007 Jan;97(1):27-31.
Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.
Longstaff C; subcommittee on fibrinolysis. Development of Shiny app tools to simplify and standardize the analysis of hemostasis assay data: communication from the SSC of the ISTH. J Thromb Haemost. 2017 May;15(5):1044-1046. doi: 10.1111/jth.13656. Epub 2017 Mar 17. No abstract available.
Primary Completion
December 20, 2019
Actual (reported)Study Completion
December 20, 2019
Actual (reported)Last Updated
January 7, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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