- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02785757
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yesim DARGAUD, MD PHD
- Telefonnummer: +33 (0)4 72 11 88 25
- E-mail: ydargaud@univ-lyon1.fr
Studiesteder
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Bron, Frankrig, 69500
- Rekruttering
- Unité d'Hémostase Clinique Hôpital Louis Pradel
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Kontakt:
- Yesim Dargaud, MD, PhD
- Telefonnummer: +33 (0)4 72 11 88 25
- E-mail: ydargaud@univ-lyon1.fr
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Ledende efterforsker:
- Yesim Dargaud, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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thrombin generation assay results
Tidsramme: 7 months
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7 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Clotting activation markers: thrombin-antithrombin complexes (TAT)
Tidsramme: 7 months
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7 months
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Clotting activation markers: prothrombin fragment F1+2
Tidsramme: 7 months
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7 months
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Clotting activation markers: D-dimer
Tidsramme: 7 months
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7 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012.788
- 2013-A00065-40 (Anden identifikator: ID-RCB)
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