Study Summary
This trial found that VTE can be the earliest sign of cancer and that identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care.
Eligible Conditions
- Blood Clot
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: At 1 year of follow-up
At 1 month
Occult cancer diagnosed by screening strategies
Year 1
Additional tests
Cost effectiveness analysis
Decision aid to assist patients in the decision of cancer screening
Early vs Adanced-stage cancers
Occult cancer missed by screening strategies
Recurrent VTE
Year 5
Cancer-related mortality
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Limited cancer screening
1 of 2
Limited cancer screening + FDG PET/CT
1 of 2
Active Control
Experimental Treatment
1276 Total Participants · 2 Treatment Groups
Primary Treatment: Limited cancer screening + FDG PET/CT · No Placebo Group · N/A
Limited cancer screening + FDG PET/CT
DiagnosticTest
Experimental Group · 1 Intervention: Limited cancer screening + FDG PET/CT · Intervention Types: DiagnosticTestLimited cancer screening
DiagnosticTest
ActiveComparator Group · 1 Intervention: Limited cancer screening · Intervention Types: DiagnosticTestTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year of follow-up
Who is running the clinical trial?
Ministry of Health, FranceOTHER_GOV
364 Previous Clinical Trials
362,196 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,268 Previous Clinical Trials
25,600,299 Total Patients Enrolled
Ottawa Hospital Research InstituteOTHER
544 Previous Clinical Trials
2,516,731 Total Patients Enrolled
University Hospital, BrestLead Sponsor
483 Previous Clinical Trials
223,189 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Carrier, Marc, Alejandro Lazo-Langner, Sudeep Shivakumar, Vicky Tagalakis, Ryan Zarychanski, Susan Solymoss, Nathalie Routhier, et al.. 2015. “Screening for Occult Cancer in Unprovoked Venous Thromboembolism”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1506623.
- van Es, Nick, Grégoire Le Gal, Hans-Martin Otten, Philippe Robin, Andrea Piccioli, Ramón Lecumberri, Luis Jara-Palomares, et al.. 2017. “Screening for Occult Cancer in Patients with Unprovoked Venous Thromboembolism”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m17-0868.
- Robin, Philippe, Pierre-Yves Le Roux, Benjamin Planquette, Sandrine Accassat, Pierre-Marie Roy, Francis Couturaud, Nadia Ghazzar, et al.. 2016. “Limited Screening with Versus Without 18f-fluorodeoxyglucose PET/CT for Occult Malignancy in Unprovoked Venous Thromboembolism: An Open-label Randomised Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00480-5.
- Robin, Philippe, Pierre-Yves Le Roux, Benjamin Planquette, Sandrine Accassat, Pierre-Marie Roy, Francis Couturaud, Nadia Ghazzar, et al.. 2016. “Limited Screening with Versus Without 18f-fluorodeoxyglucose PET/CT for Occult Malignancy in Unprovoked Venous Thromboembolism: An Open-label Randomised Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00480-5.
- Carrier, Marc, Alejandro Lazo-Langner, Sudeep Shivakumar, Vicky Tagalakis, Ryan Zarychanski, Susan Solymoss, Nathalie Routhier, et al.. 2015. “Screening for Occult Cancer in Unprovoked Venous Thromboembolism”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1506623.
- 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.
- 2020. "Screening for Occult Malignancy in Patients With Unprovoked Venous Thromboembolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04304651.
Frequently Asked Questions
In how many locales is this investigation functioning?
"Numerous locations across Canada are recruiting participants, including the University of Calgary in Calgary, McMaster University in Hamilton, and the University of Manitoba in Winnipeg. Additionally, there are several other sites where patients may be enrolled." - Anonymous Online Contributor
Unverified Answer