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Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein (MVTEP)

Primary Purpose

Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnostic procedure
fludeoxyglucose F 18
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thromboembolism focused on measuring unspecified adult solid tumor, protocol specific, thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • 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

Sites / Locations

  • CHU Brest - Hopital De La Cavale Blanche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.

Patients only undergo standard diagnostic methods.

Outcomes

Primary Outcome Measures

Number of cancers diagnosed

Secondary Outcome Measures

Full Information

First Posted
August 21, 2009
Last Updated
December 5, 2014
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT00964275
Brief Title
Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein
Acronym
MVTEP
Official Title
Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography, may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose F 18 positron emission tomography in finding cancer. 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
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, thromboembolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients only undergo standard diagnostic methods.
Intervention Type
Procedure
Intervention Name(s)
diagnostic procedure
Intervention Description
Standard diagnostic procedures followed
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Description
PET with flueoxyglucose F 18
Primary Outcome Measure Information:
Title
Number of cancers diagnosed
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Salaun, MD
Organizational Affiliation
CHU Brest - Hopital De La Cavale Blanche
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brest - Hopital De La Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34597414
Citation
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.
Results Reference
derived
PubMed Identifier
28978463
Citation
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.
Results Reference
derived
PubMed Identifier
26672686
Citation
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.
Results Reference
derived

Learn more about this trial

Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein

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