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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04304651
Other study ID # 29BRC20.0021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date September 8, 2030

Study information

Verified date March 2024
Source University Hospital, Brest
Contact Pierre-Yves SALAUN
Phone (+33)298223327
Email pierre-yves.salaun@chu-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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%).


Description:

The identification of subgroups of patients at high risk of cancer might enable more efficient screening strategies for early detection of cancer. Venous thromboembolism (VTE) can be the first manifestation of an occult cancer. All tumor sites may be involved. In an individual patient-level data meta-analysis (IPDMA), it was reported a 1-year prevalence of occult cancer of 5.2% (95%CI 4.1-6.5) among patients presenting with unprovoked VTE. 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.


Recruitment information / eligibility

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)

Study Design


Intervention

Diagnostic Test:
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.

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Brest Canadian Institutes of Health Research (CIHR), Ministry of Health, France, Ottawa Hospital Research Institute

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (3)

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

Outcome

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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