Embolism and Thrombosis Clinical Trial
— MVTEP2/SOME2Official title:
Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients With Unprovoked Venous Thromboembolism
Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE. 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%).
Status | Recruiting |
Enrollment | 1276 |
Est. completion date | September 8, 2030 |
Est. primary completion date | September 8, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) will be eligible to participate into the study. 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: Patients will be excluded from the study if they have any of the following 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) |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | McMaster University | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Jewish General Hospital | Montréal | Quebec |
Canada | McGill University Health Centre | Montréal | Quebec |
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 | University of Manitoba | Winnipeg | Manitoba |
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 | CH des Pays de Morlaix | Morlaix | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | CHU Saint-Etienne | Saint-Etienne | |
France | Hôpital Saint Musse - CH Toulon | Toulon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest | Canadian Institutes of Health Research (CIHR), Ministry of Health, France, Ottawa Hospital Research Institute |
Canada, France,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occult cancer missed by screening strategies | Occult cancer "missed" by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening. In other words, "missed" means the number of new cancers diagnosed in patients considered not to have cancer after having completed the assigned cancer screening strategy (i.e false negative results of screening strategies). | At 1 year of follow-up | |
Secondary | Occult cancer diagnosed by screening strategies | The proportion of patients with a new cancer diagnosis after completion of the initial allocated screening strategy. | At 1 month | |
Secondary | Early vs Adanced-stage cancers | The proportion of early-stage (T1-2N0M0) as per the World Health Organization TNM classification system) versus advanced-stage tumors at initial screening and during follow-up. | At 1 year of follow-up | |
Secondary | Cancer-related mortality | Cancer-related mortality during a 5-year follow-up period. | At 5 years of follow-up | |
Secondary | Cost effectiveness analysis | Additional cost per additional cancer detected. | At 1 year of follow-up | |
Secondary | Recurrent VTE | Rate of recurrent VTE | At 1 year of follow-up | |
Secondary | Decision aid to assist patients in the decision of cancer screening | Development of a decision aid to assist patients in the decision of cancer screening | At 1 year of follow-up | |
Secondary | Additional tests | The proportion of patients receiving additional tests following each strategy | At 1 year of follow-up |
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