Venous ThrombosesCLODETTENCT05711173
Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
A study testing Additional blood sampling in people with Venous Thromboses and Thromboembolic Disease, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Venous Thromboses, Thromboembolic Disease, Neutrophil Extracellular Trap Formation
- What is being tested?
- Additional blood sampling
- How many people
- 150 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Mar 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients (male or female) less than 50 y.o with :
- Splanchnic venous territory thrombosis or
- Cerebral venous thrombosis or
- Venous thrombosis of the upper limb or
- Pulmonary embolism (1st episode if male, 2nd episode if female) unprovoked or
- 1 episode of deep vein thrombosis + 1 episode of arterial thrombosis
Who cannot join
- Presence of a major or minor transient venous thrombosis risk factor:
- Surgery within the last 3 months preceding the qualifying thrombotic episode
- Lower limb fracture with immobilization > 3 days in the last 3 months preceding the qualifying thrombotic episode
- Presence of estro-progestational contraception
- Pregnancy
- Immobilization for acute medical reasons within the last 3 months preceding the qualifying thrombotic episode
Show all 20Show fewer
- Air or car travel > 6 hours
- Presence of a major or minor persistent risk factor for venous thrombosis:
- Presence of active cancer (solid cancer or hematologic malignancy)
- Chronic inflammatory digestive or joint diseases
- Ongoing treatment with heparin (low molecular weight heparin (LMWH) or unfractionated heparin (UFH))
- Presence of an abnormality on the thrombophilia test among the following abnormalities
- Protein C deficiency
- Protein S deficiency
- Anti-thrombin deficiency
- Heterozygous or homozygous factor II mutation
- Heterozygous or homozygous factor V mutation
- Presence of anti-phospholipid syndrome
- Presence of myeloproliferative neoplasia
- Presence of paroxysmal nocturnal hemoglobinuria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHU de Bordeaux, Service de Neurologie
Bordeaux
Igor SIBON, igor.sibon@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux, Service Gastro-Entérologie
Bordeaux
Paul HERMABESSIERE, paul.hermabessiere@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Service Hématologie Biologique
Bordeaux
Alexandre GUY, alexandre.guy@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Service Médecine Vasculaire
Bordeaux
Joël CONSTANS, joel.constans@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire
Bordeaux
Sophie SKOPINSKI, sophie.skopinski@chu-bordeaux.fr
- Not yet recruiting
CHU de Lille, Service Hémostase Clinique
Lille
Nathalie TRILLOT, nathalie.trillot@chu-lille.fr
- Not yet recruiting
APHM - Hôpital de la Timone, Service Hématologie
Marseille
Pierre SUCHON, PIERRE.SUCHON@ap-hm.fr
About this study
Official title: Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.
Read the detailed description
It has recently been shown that some patients clonal have mutations at a low level in hematopoietic cells (this phenomenon is named clonal hematopoiesis of indetermined potential (CHIP)) and that the presence of a clonal hematopoiesis is associated with an increased cardiovascular risk. However, few data exist about the implication of CHIP in venous thrombosis. Neutrophils extracellular traps are involved in the activation of hemostasis and coagulation. Murine models have highlighted the crucial role of NETs in the physiopathology of venous thrombosis. In patients, studies have demonstrated that NETs markers were present in arteries lesions as coronary plaques. However, few studies have analyzed the NETosis in the setting of venous thrombosis.
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP and/or an increased NETosis formation, which may represent a predisposition for the occurrence of venous thrombosis. We also speculate that patients with CHIP may have an increased NETosis, due to the presence of activating clonal mutations in neutrophils.
Patients included will be : younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites (cerebral venous thrombosis, splanchnic thrombosis) with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors. In this population, we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers.
- Conditions
- Venous Thromboses, Thromboembolic Disease, Neutrophil Extracellular Trap Formation, Clonal Hematopoiesis of Indeterminate Potential
- Being tested
- Additional blood sampling
- Keywords
- Thrombosis, Venous thrombosis, Clonal hematopoiesis of indetermined potential
- Medical subject headings
- Venous Thrombosis, Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplingBiological
The procedure will consist of an additional blood sample for ETDA tube collection (NGS analysis) and citrate tube collection (NETose analysis)
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of clonal hematopoiesis
The existence of clonal hematopoiesis will be defined as the demonstration of at least one mutation in the blood cells of an apparently healthy subject (without obvious hematological pathology). DNA will be extracted from circulating leukocytes to search for mutations in a panel of 59 genes
Measured: At baseline
Secondary outcomes (7)
Presence of one or more increased NETosis markers and/or a decreased NETosis-inhibiting marker (DNAse level) compared to a control population.
Analysis of the following markers: MPO-DNA complex, Histone 3-DNA complex, citrullinated histone 3, DNAse
Measured: At baseline
Correlation (correlation coefficient values) between the presence of a CHIP and the formation of NETs
Correlation analysis will be performed between each NETosis marker and CHIP evaluation (presence or absence, number of mutations, variant allele frequency for each mutation)
Measured: During final analysis
Allele frequency
Variant allele frequency of each detected mutation will be determined using NGS analysis
Measured: At baseline
Number of clonal mutations
The number of clonal mutations for each patient will be determined using NGS analysis
Measured: At baseline
C-reactive protein (CRP) level as a marker of inflammation
C-reactive protein concentration will be determined for each patient, as a marker of inflammation
Measured: At baseline
Site(s) of thrombosis
Site(s) of thrombosis will be determined during examination of the patient
Measured: At baseline
Number of thrombosis
The number of thrombosis will be determined during examination of the patient
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start3 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre GUY, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711173
- Sponsor's protocol ID
- CHUBX 2022/32
- Acronym
- CLODETTE
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2023
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
- ClinicalTrials.gov ID
- NCT05711173
- Acronym / sponsor ID
- CLODETTE / CHUBX 2022/32
- Conditions
- Venous Thromboses, Thromboembolic Disease, Neutrophil Extracellular Trap Formation, Clonal Hematopoiesis of Indeterminate Potential
- Keywords
- Thrombosis, Venous thrombosis, Clonal hematopoiesis of indetermined potential
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Feb 2023 (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.
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.
Detailed description
It has recently been shown that some patients clonal have mutations at a low level in hematopoietic cells (this phenomenon is named clonal hematopoiesis of indetermined potential (CHIP)) and that the presence of a clonal hematopoiesis is associated with an increased cardiovascular risk. However, few data exist about the implication of CHIP in venous thrombosis. Neutrophils extracellular traps are involved in the activation of hemostasis and coagulation. Murine models have highlighted the crucial role of NETs in the physiopathology of venous thrombosis. In patients, studies have demonstrated that NETs markers were present in arteries lesions as coronary plaques. However, few studies have analyzed the NETosis in the setting of venous thrombosis.
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP and/or an increased NETosis formation, which may represent a predisposition for the occurrence of venous thrombosis. We also speculate that patients with CHIP may have an increased NETosis, due to the presence of activating clonal mutations in neutrophils.
Patients included will be : younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites (cerebral venous thrombosis, splanchnic thrombosis) with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors. In this population, we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients (male or female) less than 50 y.o with :
- Splanchnic venous territory thrombosis or
- Cerebral venous thrombosis or
- Venous thrombosis of the upper limb or
- Pulmonary embolism (1st episode if male, 2nd episode if female) unprovoked or
Key exclusion criteria (20 listed)
- Presence of a major or minor transient venous thrombosis risk factor:
- Surgery within the last 3 months preceding the qualifying thrombotic episode
- Lower limb fracture with immobilization > 3 days in the last 3 months preceding the qualifying thrombotic episode
- Presence of estro-progestational contraception
- Pregnancy
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 |
|---|---|---|
| Additional blood samplingThe procedure will consist of an additional blood sample for ETDA tube collection (NGS analysis) and citrate tube collection (NETose analysis) | Biological | – |
Primary outcome
Presence of clonal hematopoiesis
Time frame: At baseline
The existence of clonal hematopoiesis will be defined as the demonstration of at least one mutation in the blood cells of an apparently healthy subject (without obvious hematological pathology). DNA will be extracted from circulating leukocytes to search for mutations in a panel of 59 genes
7 secondary outcomes
Presence of one or more increased NETosis markers and/or a decreased NETosis-inhibiting marker (DNAse level) compared to a control population.
Time frame: At baseline
Correlation (correlation coefficient values) between the presence of a CHIP and the formation of NETs
Time frame: During final analysis
Allele frequency
Time frame: At baseline
Number of clonal mutations
Time frame: At baseline
C-reactive protein (CRP) level as a marker of inflammation
Time frame: At baseline
Site(s) of thrombosis
Time frame: At baseline
Number of thrombosis
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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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.
Alexandre GUY principal investigator
University Hospital, Bordeaux
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood sampling in people with Venous Thromboses and Thromboembolic Disease, run by University Hospital, Bordeaux at 7 sites 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre GUY (0557656478, alexandre.guy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of clonal hematopoiesis (time frame: At baseline). 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 21 Mar 2025.