RecruitingNot ApplicableNCT04304651

Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism

Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients with Unprovoked Venous Thromboembolism


Sponsor

University Hospital, Brest

Enrollment

1,276 participants

Start Date

Sep 8, 2020

Study Type

INTERVENTIONAL

Conditions

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%).


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a thorough cancer screening (including CT scans, colonoscopy, and other tests) can detect hidden cancers in people who have had an unexplained blood clot (deep vein thrombosis or pulmonary embolism) — since new blood clots without an obvious cause can sometimes be an early sign of cancer. **You may be eligible if...** - You are 50 years old or older - You have been newly diagnosed with a first unprovoked blood clot in a deep vein or lungs (DVT or pulmonary embolism) - Your blood clot has no obvious cause (no recent surgery, immobilization, cancer diagnosis, or other known risk factors) **You may NOT be eligible if...** - You have a known active cancer - You had a blood clot after prolonged bed rest, recent surgery, pregnancy, or other recognized trigger - You recently received hormonal therapy or oral contraceptives - Your overall health status suggests cancer may already be present at the time of the clot Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLimited 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.

DIAGNOSTIC_TESTLimited cancer screening + FDG PET/CT

The limited cancer screening (as described above) in combination with a FDG PET/CT.


Locations(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, 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

View Full Details on ClinicalTrials.gov

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NCT04304651


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