Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH

NCT02552381 | Completed

• 1 other identifier: FICT 2015-A00501-48
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Tumor

Keywords

Cancer; Thromboembolic event; Fibrin Structure; LMWH

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (3)

Group I

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.

Other: Fibrin Structure

Group II

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.

Other: Fibrin Structure

Group III

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.

Other: Fibrin Structure

Interventions

Fibrin Structure OTHER

Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.

Group I; Group II; Group III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Internal Medicine Department, in a French Hospital

You may qualify if:

• patients with non-opposition to participate in the evaluation
• patients from Internal Medicine Department
• patients affected with all types of malignancies, treated or not with LMWH

You may not qualify if:

• patients treated with VKA or with recent surgery (within one month)
• patients with a condition known to cause a coagulation activation status other than cancer (sepsis, pneumonia,..)

Sponsors & Collaborators

• Diagnostica Stago R&D: lead
• Hôpital Louis Mourier: collaborator
• Hopital Lariboisière: collaborator

Study Sites (1)

Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)

Colombes, 92701, France

Location

Related Publications (6)

• 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.

  PMID: 22099399 BACKGROUND

• 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.

  PMID: 20886193 BACKGROUND

• 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.

  PMID: 12192305 BACKGROUND

• 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.

  PMID: 17200767 BACKGROUND

• 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.

  PMID: 29658191 BACKGROUND

• 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.

  PMID: 28304129 BACKGROUND

Related Links

• Recommandations internationales pour le traitement et la prophylaxie de la thromboembolie veineuse chez le patient cancéreux. GFTC, Communiqué de presse, 26 Juin 2013
• Patent : Juillet 2015, Method for determining the structural profile of a fibrin clot reflecting the stability thereof, in order to predict the risk of bleeding, thrombosis or rethrombosis

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen citrated Poor Platelets Plasma

MeSH Terms

Conditions

Neoplasms; Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Isabelle Mahe, MD, PhD

  Université of Paris 7 - Paris Diderot

  PRINCIPAL INVESTIGATOR

• Geneviève Contant, PhD

  Diagnostica Stago

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: September 17, 2015
• Study Start: August 1, 2015
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

FR (1)