Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein
NCT ID: NCT00964275
Last Updated: 2014-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2009-03-31
2014-10-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.
Detailed Description
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Primary
* Demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of PET-CT with 18-FDG in patients with idiopathic venous thromboembolism.
Secondary
* Assess the risk of cancer detected at 1 year.
* Assess whether PET allows earlier detection of cancer.
* Evaluate survival.
OUTLINE: This is a multicenter study.
All patients undergo standard (clinical and biological) diagnostic tests for cancer. Patients are randomized to 1 of 2 diagnostic arms.
* Arm I: Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
* Arm II: Patients only undergo standard diagnostic methods. Patients are followed up for 2 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm I
Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
fludeoxyglucose F 18
PET with flueoxyglucose F 18
Arm II
Patients only undergo standard diagnostic methods.
diagnostic procedure
Standard diagnostic procedures followed
Interventions
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diagnostic procedure
Standard diagnostic procedures followed
fludeoxyglucose F 18
PET with flueoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of idiopathic venous thromboembolism (IVTE) meeting 1 of the following criteria:
* Newly diagnosed
* Recurrent disease controlled by anticoagulant therapy
* No IVTE caused by a reversible major risk factor
* No IVTE caused by a major constitutional risk factor, including any of the following:
* Antiphospholipid antibody syndrome
* Antithrombin deficit
* Protein C
* Protein S
PATIENT CHARACTERISTICS:
* Not pregnant
* No other known active cancer at the onset of IVTE
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Pierre-Yves Salaun, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Brest - Hopital De La Cavale Blanche
Locations
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CHU Brest - Hopital De La Cavale Blanche
Brest, , France
Countries
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References
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Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10(10):CD010837. doi: 10.1002/14651858.CD010837.pub5.
Robin P, Le Roux PY, Tromeur C, Planquette B, Prevot-Bitot N, Lavigne C, Pastre J, Merah A, Couturaud F, Le Gal G, Salaun PY. Risk factors of occult malignancy in patients with unprovoked venous thromboembolism. Thromb Res. 2017 Nov;159:48-51. doi: 10.1016/j.thromres.2017.08.021. Epub 2017 Sep 28.
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.
Other Identifiers
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HCB-MVTEP
Identifier Type: -
Identifier Source: secondary_id
RB 08-062
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0945
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-004135-38
Identifier Type: -
Identifier Source: secondary_id
CDR0000639720
Identifier Type: -
Identifier Source: org_study_id