Clinical trial NCT01727427: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
Official title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unsuspected Pulmonary Embolism
Keywords: Unsuspected
pulmonary embolism
cancer
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All ambulatory or hospitalized cancer patients with a first diagnosis of unsuspected PE. Both solid and hematological cancers at any stage of disease will be considered for inclusion

Brief summary: The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.


Eligibility criteria: Inclusion Criteria:

* cancer patients with a first diagnosis of unsuspected PE

Exclusion Criteria:

1. age \<18 years;
2. ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
3. life expectancy less than 3 months.

Primary outcomes:
measure: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
timeFrame: one year
Secondary outcomes:
measure: Major, clinically relevant non-major bleeding, and minor bleeding
timeFrame: one year
Other outcomes:
measure: Mortality
timeFrame: one year
Locations:
city: Washington
country: United States
facility: D.C. Veterans Affairs Medical Center
state: District of Columbia
city: Vienna
country: Austria
facility: Clinical Division of Haematology, Department of Medicine I
city: Ottawa
country: Canada
facility: Division of Hematology, University of Ottawa
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Arras
country: France
facility: Arras/Onco Nord Pas de Callais, Loos
city: Bordeaux
country: France
facility: Hopital Saint André
city: Brest, Cedex
country: France
facility: University hospital Centra La Cavale Blanche
city: Brest
country: France
facility: Brest HIA Clermont Tonnerre
city: Castelnau
country: France
facility: Montpellier et clinique du parc a Castelnau le nez
city: Clermont
country: France
facility: Hopital G. Montpied Clermont-Ferrand
city: Colombes
country: France
facility: AP-HP Hopital Louis Mourier
city: Dijon
country: France
facility: Laboratoire d'Hématologie, Dijon
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Loriboisière
city: Paris
country: France
facility: Hospital Pitie Salpetriere
city: Saint-Etienne
country: France
facility: Service de médecine et Thérapeutique
city: Dresden
country: Germany
facility: Division of Vascular Medicine, Department of Medicine, Technical University Dresden
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Chieti
country: Italy
facility: Universita degli Studi G. d'Annunzio Chieti e Pescara
city: Palermo
country: Italy
facility: Malattie Cardiovascolari e Nefrourologiche
city: Pavia
country: Italy
facility: Fondazione IRCCS
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)
city: Varese
country: Italy
facility: Università dell'Insubria
city: Amsterdam
country: Netherlands
facility: Slotervaart hospital
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: National Cancer Institute - Antonie van Leeuwenhoek hospital
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sabadell
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Barcelona
country: Spain
facility: ICO_Hospital Duran i Reynals
city: Benidorm
country: Spain
facility: Hospital Clinico Benidorm, Alicante
city: Las Palmas
country: Spain
facility: Hospital Universitario Insular de Gran Canarias
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario de Móstoles
city: Madrid
country: Spain
facility: Hospital Universitario Infantia Sofia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Orense
country: Spain
facility: Hospital Santa María Nei
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Teruel
country: Spain
facility: Hospital Obispo Polanco
city: Toledo
country: Spain
facility: Hospital Nuestra Sra del Prado Talavera de la Reina
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcello Di Nisio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraaijpoel N, Bleker SM, Meyer G, Mahe I, Munoz A, Bertoletti L, Bartels-Rutten A, Beyer-Westendorf J, Porreca E, Boulon C, van Es N, Iosub DI, Couturaud F, Biosca M, Lerede T, Lacroix P, Maraveyas A, Aggarwal A, Girard P, Buller HR, Di Nisio M; UPE investigators. Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study. J Clin Oncol. 2019 Jul 10;37(20):1713-1720. doi: 10.1200/JCO.18.01977. Epub 2019 May 22.