Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism
NCT ID: NCT04304651
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1276 participants
INTERVENTIONAL
2020-09-08
2030-09-08
Brief Summary
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An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).
Detailed Description
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Two recent multicenter randomized controlled trials (e.g. SOME (Canada) and MVTEP (France) trials) failed to demonstrate that extensive cancer screening strategies diagnosed more cancers, more early stage tumors, or improved cancer-related mortality in comparison with a more limited screening strategy. However, the main limitation of these studies was the twice lower than expected overall incidence of occult cancer diagnosis in unselected patients with unprovoked VTE, which limited the statistical power. In the IPDMA, it was also reported that the 1-year period prevalence of occult cancer was 7-fold higher in patients aged ≥ 50 (6.8%; 95%CI 5.6-8.3) as compared with those \< 50 years (1.0%; 95%CI 0.5-2.3).
Moreover, in the MVTEP trial, the incidence of missed cancers over a 2-years follow-up period was significantly lower in patients randomized to a 18F-Fluorodeoxyglucose Positron Emission/Computed Tomography (FDG-PET/CT) screening strategy. Thus, the most promising diagnostic modality for occult cancer screening seems to be FDG-PET/CT. FDG-PET/CT which allows a one-stop whole-body imaging, is routinely used for the diagnosis, staging and restaging of various cancers.
The MVTEP2 Trial seeks to determine if among higher risk patients (≥ 50 year-old) with a first unprovoked VTE, a cancer screening strategy including a FDG-PET/CT decreases the number of missed occult cancers detected over a 1-year follow-up period as compared with a limited screening alone.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Limited cancer screening
Limited screening alone.
Limited cancer screening
The limited cancer screening will include: 1) a complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin); and 4) chest X-ray.
In women, a breast examination, Pap smear/pelvic examination (if \< 70 years old and previously sexually active) and mammogram will be performed, if not conducted in last year.
In men, similarly, prostate examination and PSA testing will be performed, if not conducted in the last year.
All patients will undergo colon cancer screening as per local practice.
Limited cancer screening + FDG PET/CT
Limited screening + FDG PET/CT
Limited cancer screening + FDG PET/CT
The limited cancer screening (as described above) in combination with a FDG PET/CT.
Interventions
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Limited cancer screening
The limited cancer screening will include: 1) a complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin); and 4) chest X-ray.
In women, a breast examination, Pap smear/pelvic examination (if \< 70 years old and previously sexually active) and mammogram will be performed, if not conducted in last year.
In men, similarly, prostate examination and PSA testing will be performed, if not conducted in the last year.
All patients will undergo colon cancer screening as per local practice.
Limited cancer screening + FDG PET/CT
The limited cancer screening (as described above) in combination with a FDG PET/CT.
Eligibility Criteria
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Inclusion Criteria
Unprovoked VTE is defined as the absence of any of the following predisposing factors:
1. active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma; Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol
2. recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
3. recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
4. previous unprovoked VTE;
5. known thrombophilia (hereditary or acquired)
Exclusion Criteria
1. Refusal or inability to provide informed consent;
2. Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
3. Unavailable to follow-up.
4. VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
50 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Hospital Research Institute
OTHER
University Hospital, Brest
OTHER
Responsible Party
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Locations
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University of Calgary
Calgary, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Hopital Montfort
Ottawa, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CH des Pays de Morlaix
Morlaix, France, France
CH Agen
Agen, , France
CHU Angers
Angers, , France
Brest University Hospital
Brest, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Dijon
Dijon, , France
CHU de Limoges
Limoges, , France
Hôpital Européen Georges Pompidou
Paris, , France
CHU Saint-Etienne
Saint-Etienne, , France
Hôpital Saint Musse - CH Toulon
Toulon, , France
Countries
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Central Contacts
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Facility Contacts
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Leslie Skeith
Role: primary
Ryan Zarychanski
Role: primary
Deborah Siegal
Role: primary
Alejandro Lazno-Langner
Role: primary
Gregoire Le Gal
Role: primary
Aurélien DELLUC
Role: primary
Marc CARRIER
Role: backup
Grégoire LE GAL
Role: backup
Jean-Phillippe Galanaud
Role: primary
Erik Yeo
Role: primary
Jameel Abdulrehman
Role: backup
Vicky Tagalakis
Role: primary
Susan Solymoss
Role: primary
David RENAUD, Dr
Role: primary
RORIZ Mélanie
Role: primary
Alexandre-Xavier BOISSON
Role: backup
Pierre-Marie ROY
Role: primary
Pierre-Yves SALAUN
Role: primary
Philippe ROBIN
Role: backup
Francis COUTURAUD
Role: backup
Pierre-Yves LE ROUX
Role: backup
Jeannot SCHMIDT
Role: primary
Nicolas FALVO
Role: primary
Philippe LACROIX
Role: primary
Olivier SANCHEZ
Role: primary
Laurent BERTOLETTI
Role: primary
Antoine ELIAS
Role: primary
References
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Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.
Carrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22.
van Es N, Le Gal G, Otten HM, Robin P, Piccioli A, Lecumberri R, Jara-Palomares L, Religa P, Rieu V, Rondina M, Beckers MM, Prandoni P, Salaun PY, Di Nisio M, Bossuyt PM, Buller HR, Carrier M. Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data. Ann Intern Med. 2017 Sep 19;167(6):410-417. doi: 10.7326/M17-0868. Epub 2017 Aug 22.
Other Identifiers
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29BRC20.0021
Identifier Type: -
Identifier Source: org_study_id