ThromboembolismMVTEPNCT00964275
Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein
A study testing diagnostic procedure and fludeoxyglucose F 18 in people with Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- diagnostic procedure and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism
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.
Read the 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.
- Being tested
- diagnostic procedure, fludeoxyglucose F 18
- Keywords
- unspecified adult solid tumor, protocol specific, thromboembolism
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic procedureProcedure or surgery
Standard diagnostic procedures followed
fludeoxyglucose F 18Radiation
PET with flueoxyglucose F 18
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods. Receives: Radiation: fludeoxyglucose F 18 |
| Arm II | Active comparator | Patients only undergo standard diagnostic methods. Receives: Procedure: diagnostic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cancers diagnosed
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Salaun, MD, Principal investigator, CHU Brest - Hopital De La Cavale Blanche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964275
- Sponsor's protocol ID
- CDR0000639720
- Other IDs
- HCB-MVTEP, RB 08-062, INCA-RECF0945, EUDRACT-2008-004135-38
- Acronym
- MVTEP
- Status last verified
- Dec 2014
- First submitted
- 21 Aug 2009
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34597414Robin 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.
PubMed 28978463Robin 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.
PubMed 26672686
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT00964275
- Acronym / sponsor ID
- MVTEP / CDR0000639720
- Keywords
- unspecified adult solid tumor, protocol specific, thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: fludeoxyglucose F 18Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods. |
| Arm II | Active comparator | Procedure: diagnostic procedurePatients only undergo standard diagnostic methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic procedureStandard diagnostic procedures followed | Procedure or surgery | Arm II |
| fludeoxyglucose F 18PET with flueoxyglucose F 18 | Radiation | Arm I |
Primary outcome
Number of cancers diagnosed
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 34597414Robertson 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.
- Derived from this study: PubMed 28978463Robin 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.
- Derived from this study: PubMed 26672686Robin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Salaun, MD principal investigator
CHU Brest - Hopital De La Cavale Blanche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic procedure and fludeoxyglucose F 18 in people with Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cancers diagnosed (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00964275, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.