Venous ThromboembolismVTE-IDNCT06258694
Venous Thrombo-Embolism Imaging Database (VTE-ID)
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by University Hospital, Brest at 1 site in France.
Trial summary
The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 2,208 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 15 Feb 2021
- Phase
- Observational
- 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
Study population: Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.
Who may be able to join
- 18 years or older.
- Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
- Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019.
- No opposition to be included in the present study.
Who cannot join
- Patients under 18 years old.
- Patients under judicial protection.
- Patient physically or cognitively unable to give consent.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venous Thrombo-Embolism Imaging Database
The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.
Read the detailed description
Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients.
These imaging biomarkers will be validated using an internal cross validation technique.
- Keywords
- Venous thromboembolism, Image processing, Radiomics
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE recurrence
VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis
Measured: At enrollment (retrospective follow up to 2 years)
Distinguishing provoked from unprovoked VTE
Provoked VTE is defined by the presence within the three past months, of a major risk factor (i.e. Surgery, Immobilization > 3 days, Hormonal Treatment, Pregnancy, Cancer)
Measured: At enrollment
Secondary outcomes (1)
Individual phenotyping
Correlation of the identified biomarkers with VTE phenotypes (familial history, risk factor in case of provoked VTE, and biological biomarkers as fibrinogen, D Dimeres, Hemoglobin, Platelets, CRP, heterozygous or homozygous FV Leiden, Prothrombin G20210A).
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start14 Jan 2021
- Primary completion14 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258694
- Sponsor's protocol ID
- 29BRC20.0326 - VTE-ID
- Acronym
- VTE-ID
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thrombo-Embolism Imaging Database
- ClinicalTrials.gov ID
- NCT06258694
- Acronym / sponsor ID
- VTE-ID / 29BRC20.0326 - VTE-ID
- Keywords
- Venous thromboembolism, Image processing, Radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,208 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 14 Feb 2024 (actual)
- 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.
The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.
Detailed description
Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients.
These imaging biomarkers will be validated using an internal cross validation technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.
Key inclusion criteria (4 listed)
- 18 years or older.
- Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
- Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019.
- No opposition to be included in the present study.
Key exclusion criteria (4 listed)
- Patients under 18 years old.
- Patients under judicial protection.
- Patient physically or cognitively unable to give consent.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VTE recurrence
Time frame: At enrollment (retrospective follow up to 2 years)
VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis
Distinguishing provoked from unprovoked VTE
Time frame: At enrollment
Provoked VTE is defined by the presence within the three past months, of a major risk factor (i.e. Surgery, Immobilization > 3 days, Hormonal Treatment, Pregnancy, Cancer)
1 secondary outcome
Individual phenotyping
Time frame: At enrollment
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 14 Feb 2024.
Related trials for Venous Thromboembolism
RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
Active, not recruitingObservational study
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Cardiovascular Diseases, Pulmonary Embolism
Not yet recruitingObservational study
TOF-MRV Versus Post-Contrast 3D T1 MRI in Dural Venous Sinus Thrombosis
Cerebral Thrombosis, Venous Thrombosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 14 Feb 2024. 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?
VTE recurrence (time frame: At enrollment (retrospective follow up to 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.