Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
CLODETTE
Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
1 other identifier
interventional
150
1 country
7
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 21, 2025
March 1, 2025
4 years
January 24, 2023
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
At baseline
Correlation (correlation coefficient values) between the presence of a CHIP and the formation of NETs
During final analysis
Allele frequency
At baseline
Number of clonal mutations
At baseline
C-reactive protein (CRP) level as a marker of inflammation
At baseline
- +2 more secondary outcomes
Interventions
The procedure will consist of an additional blood sample for ETDA tube collection (NGS analysis) and citrate tube collection (NETose analysis)
Eligibility Criteria
You may qualify if:
- 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
- episode of deep vein thrombosis + 1 episode of arterial thrombosis
You may not qualify if:
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHU de Bordeaux, Service de Neurologie
Bordeaux, France
CHU de Bordeaux, Service Gastro-Entérologie
Bordeaux, France
CHU de Bordeaux, Service Hématologie Biologique
Bordeaux, France
CHU de Bordeaux, Service Médecine Vasculaire
Bordeaux, France
CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire
Bordeaux, France
CHU de Lille, Service Hémostase Clinique
Lille, France
APHM - Hôpital de la Timone, Service Hématologie
Marseille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre GUY
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2023
First Posted
February 2, 2023
Study Start
March 3, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 21, 2025
Record last verified: 2025-03