Screening for hidden cancers in patients with unexplained blood clots
Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients with Unprovoked Venous Thromboembolism
This study tests if combining regular cancer screenings with special imaging can help find hidden cancers earlier in people over 50 who have unexplained blood clots.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1276 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 20 sites (Calgary, Alberta and 19 other locations) |
| Trial ID | NCT04304651 on ClinicalTrials.gov |
What this trial studies
This study aims to identify occult cancers in patients over 50 years old who have been diagnosed with unprovoked venous thromboembolism (VTE). It will compare the effectiveness of limited cancer screening versus limited screening combined with FDG PET/CT imaging. The goal is to improve early detection of cancer, which can be the first sign of an underlying malignancy in these patients. The study builds on previous findings that suggest a higher prevalence of occult cancer in older patients with unprovoked VTE.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis or pulmonary embolism.
Not a fit: Patients with known malignancies or other significant predisposing factors for VTE will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier cancer detection and improved patient outcomes for those with unprovoked VTE.
How similar studies have performed: Previous studies have shown mixed results, but this approach focuses on a specific high-risk population, which may enhance its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Calgary, Alberta and 19 other locations
- University of Calgary — Calgary, Alberta, Canada (Not_yet_recruiting)
- University of Manitoba — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- McMaster University — Hamilton, Ontario, Canada (Not_yet_recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
- Hopital Montfort — Ottawa, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Not_yet_recruiting)
- CH des Pays de Morlaix — Morlaix, France, France (Recruiting)
- CH Agen — Agen, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- Brest University Hospital — Brest, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Dijon — Dijon, France (Recruiting)
- CHU de Limoges — Limoges, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
- CHU Saint-Etienne — Saint-Etienne, France (Recruiting)
- Hôpital Saint Musse - CH Toulon — Toulon, France (Recruiting)
Study contacts
- Study coordinator: Pierre-Yves SALAUN
- Email: pierre-yves.salaun@chu-brest.fr
- Phone: (+33)298223327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.