Unsuspected Pulmonary EmbolismNCT01727427
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
An observational study of Unsuspected Pulmonary Embolism, run by G. d'Annunzio University at 46 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unsuspected Pulmonary Embolism
- What is being tested?
- Heparin, fondaparinux, vitamin-K antagonists, aspirin
- Type of treatment
- Pill or oral medicine
- How many people
- 695 participants
- Where
- 46 sitesin 8 countries
- Study dates
- Nov 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- cancer patients with a first diagnosis of unsuspected PE
Who cannot join
- age <18 years;
- ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
- life expectancy less than 3 months.
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
Spain18 sites
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital de Sabadell
Barcelona
Hospital Vall D'Hebron
Barcelona
ICO_Hospital Duran i Reynals
Barcelona
Hospital Clinico Benidorm, Alicante
Benidorm
Hospital Universitario Insular de Gran Canarias
Las Palmas
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario de Móstoles
Madrid
Hospital Universitario Infantia Sofia
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario San Carlos
Madrid
Hospital Santa María Nei
Ourense
Hospital Universitario de Salamanca
Salamanca
Hospital Obispo Polanco
Teruel
Hospital Nuestra Sra del Prado Talavera de la Reina
Toledo
Hospital Universitario Dr. Peset
Valencia
France15 sites
CHU Amiens Picardie
Amiens
Arras/Onco Nord Pas de Callais, Loos
Arras
Hopital Saint André
Bordeaux
Brest HIA Clermont Tonnerre
Brest
University hospital Centra La Cavale Blanche
Brest
Montpellier et clinique du parc a Castelnau le nez
Castelnau
Hopital G. Montpied Clermont-Ferrand
Clermont
AP-HP Hopital Louis Mourier
Colombes
Laboratoire d'Hématologie, Dijon
Dijon
CHU de Limoges
Limoges
Centre Hospitalier Lyon-Sud
Lyon
Hopital Europeen Georges Pompidou
Paris
Hopital Loriboisière
Paris
Hospital Pitie Salpetriere
Paris
Service de médecine et Thérapeutique
Saint-Etienne
Italy6 sites
Ospedali Riuniti
Bergamo
Universita degli Studi G. d'Annunzio Chieti e Pescara
Chieti, 66100
Malattie Cardiovascolari e Nefrourologiche
Palermo
Fondazione IRCCS
Pavia
Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)
Reggio Emilia
Università dell'Insubria
Varese
Netherlands3 sites
Slotervaart hospital
Amsterdam, 1066 EC
Academic Medical Center
Amsterdam
National Cancer Institute - Antonie van Leeuwenhoek hospital
Amsterdam
United States1 site
D.C. Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
Austria1 site
Clinical Division of Haematology, Department of Medicine I
Vienna
Germany1 site
Division of Vascular Medicine, Department of Medicine, Technical University Dresden
Dresden
About this study
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.
- Conditions
- Unsuspected Pulmonary Embolism
- Being tested
- Heparin, fondaparinux, vitamin-K antagonists, aspirin
- Keywords
- Unsuspected, pulmonary embolism, cancer
- Medical subject headings
- Pulmonary Embolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin, fondaparinux, vitamin-K antagonists, aspirinDrug
Also called Enoxaparin (Clexane), Dalteparin (Fragmin), Nadroparin (Fraxiparin), Tinzaparin (Innohep)
Parenteral or oral anticoagulant Antiplatelet agent
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulants, aspirin | Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration Receives: Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
Suspected recurrent PE with one of the following:
- new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;
- new perfusion defect of at least 75% on V/Q lung scan;
- inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography
Fatal PE is:
- PE based on objective diagnostic testing or autopsy or
- death not attributed to a documented cause and for which DVT/PE cannot be ruled out.
Suspected (recurrent) DVT with one of the following findings:
- abnormal CUS;
- an intra-luminal filling defect on venography.
Measured: one year
Secondary outcomes (1)
Major, clinically relevant non-major bleeding, and minor bleeding
Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.
Other clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life. All other bleeding events will be classified as minor.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unsuspected Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Di Nisio, G. d'Annunzio University
- Investigators
- Marcello Di Nisio, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727427
- Sponsor's protocol ID
- 215/2012
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2012
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31116676
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
- ClinicalTrials.gov ID
- NCT01727427
- Acronym / sponsor ID
- 215/2012
- Conditions
- Unsuspected Pulmonary Embolism
- Keywords
- Unsuspected, pulmonary embolism, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulants, aspirin | – | Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirinParenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- cancer patients with a first diagnosis of unsuspected PE
Key exclusion criteria (3 listed)
- age <18 years;
- ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
- life expectancy less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin, fondaparinux, vitamin-K antagonists, aspirinAlso: Enoxaparin (Clexane), Dalteparin (Fragmin), Nadroparin (Fraxiparin), Tinzaparin (Innohep)Parenteral or oral anticoagulant Antiplatelet agent | Drug | Anticoagulants, aspirin |
Primary outcome
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
Time frame: one year
Suspected recurrent PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. death not attributed to a documented cause and for which DVT/PE cannot be ruled out. Suspected (recurrent) DVT with one of the following findings: 1. abnormal CUS; 2. an intra-luminal filling defect on venography.
1 secondary outcome
Major, clinically relevant non-major bleeding, and minor bleeding
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 31116676Kraaijpoel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Di Nisio, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unsuspected Pulmonary Embolism, run by G. d'Annunzio University at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Spain, France, Italy, Netherlands, United States and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.