NCT00964275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

5.6 years

First QC Date

August 21, 2009

Last Update Submit

December 5, 2014

Conditions

ThromboembolismUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificthromboembolism

Outcome Measures

Primary Outcomes (1)

  • Number of cancers diagnosed

    24 months

Study Arms (2)

Arm I

EXPERIMENTAL

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

Radiation: fludeoxyglucose F 18

Arm II

ACTIVE COMPARATOR

Patients only undergo standard diagnostic methods.

Procedure: diagnostic procedure

Interventions

diagnostic procedurePROCEDURE

Standard diagnostic procedures followed

Arm II
fludeoxyglucose F 18RADIATION

PET with flueoxyglucose F 18

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CHU Brest - Hopital De La Cavale Blanche

Brest, 29200, France

Location

Related Publications (3)

  • 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.

    PMID: 34597414DERIVED

  • 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.

    PMID: 28978463DERIVED

  • 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.

    PMID: 26672686DERIVED

MeSH Terms

Conditions

Thromboembolism

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Pierre-Yves Salaun, MD

    CHU Brest - Hopital De La Cavale Blanche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 24, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

FR(1)