Cancer-related Thromboembolic Disease (PROSPECT)
The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yesim DARGAUD, MD PHD
- Numéro de téléphone: +33 (0)4 72 11 88 25
- E-mail: ydargaud@univ-lyon1.fr
Lieux d'étude
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Bron, France, 69500
- Recrutement
- Unité d'Hémostase Clinique Hôpital Louis Pradel
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Contact:
- Yesim Dargaud, MD, PhD
- Numéro de téléphone: +33 (0)4 72 11 88 25
- E-mail: ydargaud@univ-lyon1.fr
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Chercheur principal:
- Yesim Dargaud, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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thrombin generation assay results
Délai: 7 months
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7 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Clotting activation markers: thrombin-antithrombin complexes (TAT)
Délai: 7 months
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7 months
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Clotting activation markers: prothrombin fragment F1+2
Délai: 7 months
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7 months
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Clotting activation markers: D-dimer
Délai: 7 months
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7 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012.788
- 2013-A00065-40 (Autre identifiant: ID-RCB)
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