Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism
MVTEP2/SOME2
1 other identifier
interventional
1,276
2 countries
20
Brief 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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
September 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 8, 2030
December 16, 2024
December 1, 2024
6 years
March 7, 2020
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Occult cancer diagnosed by screening strategies
At 1 month
Early vs Adanced-stage cancers
At 1 year of follow-up
Cancer-related mortality
At 5 years of follow-up
Cost effectiveness analysis
At 1 year of follow-up
Recurrent VTE
At 1 year of follow-up
- +2 more secondary outcomes
Study Arms (2)
Limited cancer screening
ACTIVE COMPARATORLimited screening alone.
Limited cancer screening + FDG PET/CT
EXPERIMENTALLimited screening + FDG PET/CT
Interventions
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.
The limited cancer screening (as described above) in combination with a FDG PET/CT.
Eligibility Criteria
You may qualify if:
- 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:
- 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
- recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
- recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
- previous unprovoked VTE;
- known thrombophilia (hereditary or acquired)
You may not qualify if:
- Patients will be excluded from the study if they have any of the following criteria:
- Refusal or inability to provide informed consent;
- Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
- Unavailable to follow-up.
- VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Brestlead
- Ministry of Health, Francecollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- Ottawa Hospital Research Institutecollaborator
Study Sites (20)
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, 29600, 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
Related Publications (3)
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.
PMID: 26672686BACKGROUNDCarrier 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.
PMID: 26095467BACKGROUNDvan 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.
PMID: 28828492BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2020
First Posted
March 11, 2020
Study Start
September 8, 2020
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2030
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication