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Cancer-related Thromboembolic Disease (PROSPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02785757
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.

The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk

The secondary objectives are:

  • To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
  • To evaluate values of other clotting activation markers in patients with cancer

Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.

Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.

The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.


Condition or disease Intervention/treatment Phase
Adenocarcinoma Other: Thrombin Generation Assay Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
Actual Study Start Date : July 12, 2014
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : February 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
Other: Thrombin Generation Assay



Primary Outcome Measures :
  1. thrombin generation assay results [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Clotting activation markers: thrombin-antithrombin complexes (TAT) [ Time Frame: 7 months ]
  2. Clotting activation markers: prothrombin fragment F1+2 [ Time Frame: 7 months ]
  3. Clotting activation markers: D-dimer [ Time Frame: 7 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
  • Subjects having signed Informed Consent prior to initiation of any study procedure
  • Covered by a Health System

Exclusion Criteria:

  • Known bleeding or thrombophilia disorders
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
  • Patient immobilized
  • Confirmed venous thromboembolism in the last 12 months
  • Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
  • Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
  • Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
  • Severe hepatic insufficiency
  • Life expectancy of less than 3 months
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785757


Contacts
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Contact: Yesim DARGAUD, MD PHD (0)4 72 11 88 25 ext +33 ydargaud@univ-lyon1.fr

Locations
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France
Unité d'Hémostase Clinique Hôpital Louis Pradel Recruiting
Bron, France, 69500
Contact: Yesim Dargaud, MD, PhD    (0)4 72 11 88 25 ext +33    ydargaud@univ-lyon1.fr   
Principal Investigator: Yesim Dargaud, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02785757    
Other Study ID Numbers: 2012.788
2013-A00065-40 ( Other Identifier: ID-RCB )
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Keywords provided by Hospices Civils de Lyon:
adenocarcinoma
venous thromboembolism
thrombin generation assay
Additional relevant MeSH terms:
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Adenocarcinoma
Thromboembolism
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombin
Hemostatics
Coagulants