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Diagnostic Test
Cancer Screening for Blood Clots (MVTEP2/SOME2 Trial)
N/A
Recruiting
Research Sponsored by University Hospital, Brest
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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: recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year of follow-up
Awards & highlights
MVTEP2/SOME2 Trial 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.
Who is the study for?
This trial is for people aged 50 or older who have had a blood clot (VTE) without any clear cause. They shouldn't have known clotting disorders, active cancer in the last 5 years, recent major surgery, paralysis, or been bedridden recently. Participants must be able to give consent and commit to follow-up appointments.Check my eligibility
What is being tested?
The study is testing two ways of screening for hidden cancers in patients with unexplained blood clots: standard limited cancer screening versus adding a special imaging test called FDG PET/CT that can find cancer.See study design
What are the potential side effects?
There may be some side effects from the FDG PET/CT scan such as allergic reactions to the tracer used in the test. However, these are generally rare and most people do not experience significant side effects.
MVTEP2/SOME2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 or older and have a new diagnosis of DVT or PE.
Select...
My blood clot was not caused by recent surgery or being bedridden.
Select...
My blood clot occurred without any known cause.
Select...
My blood clot was not caused by a previous clot.
MVTEP2/SOME2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year of follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occult cancer missed by screening strategies
Secondary outcome measures
Additional tests
Cancer-related mortality
Cost effectiveness analysis
+4 moreMVTEP2/SOME2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Limited cancer screening + FDG PET/CTExperimental Treatment1 Intervention
Limited screening + FDG PET/CT
Group II: Limited cancer screeningActive Control1 Intervention
Limited screening alone.
Find a Location
Who is running the clinical trial?
University Hospital, BrestLead Sponsor
520 Previous Clinical Trials
238,867 Total Patients Enrolled
Ministry of Health, FranceOTHER_GOV
372 Previous Clinical Trials
363,753 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,454,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clot was not caused by cancer or any known risk factors.You are allergic to 18F-FDG or any of the ingredients in the product.I am 50 or older and have a new diagnosis of DVT or PE.My blood clot was not caused by recent surgery or being bedridden.My blood clot occurred without any known cause.My blood clot was not caused by a previous clot.My blood clot was not caused by recent severe leg immobility.I had a blood clot despite being on blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Limited cancer screening
- Group 2: Limited cancer screening + FDG PET/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
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