Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism

NCT04477564 | Completed

• 1 other identifier: NIMAO/2020-01/SB-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism. The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.

Conditions

Venous Thromboembolism

Keywords

Clonal Hematopoiesis of indeterminate potential

Outcome Measures

Primary Outcomes (1)

• DNMT3A mutations screening

  Next generation sequencing

  For sequencing analysis: 2 months

Secondary Outcomes (1)

• TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening

  For sequencing analysis: 2 months

Study Arms (3)

Unprovoked proximal deep vein thrombosis

Provoked distal deep vein thrombosis

age-matched control group with no history of vein thrombosis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women over 50 years old who have consulted at the Hematology laboratory of the Nîmes University Hospital for the occurrence or history of venous thromboembolism (Distal/proximal; Provoked/unprovoked) and who has accepted that their DNA was kept and used in the context of research on venous thromboembolism

You may qualify if:

• Men and women over 50 years old who have consulted at the Hematology laboratory of the Nîmes University Hospital for the occurrence or history of venous thromboembolism
• Patient who has accepted that their DNA was kept and used in the context of research on venous thromboembolism (biobank (registration number DC-2008-290 and authorization number AC-2008-107))

You may not qualify if:

• Patients less than 50 years old
• Patient who has refused that their DNA was kept and used in the context of research on venous thromboembolism

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

Related Publications (1)

• Guillotin F, Mercier E, Fortier M, Bouvier S, Jacquet Q, Dallo M, Chea M, Bourguignon C, Cochery-Nouvellon E, Perez-Martin A, Gris JC. Clonal haematopoiesis of indeterminate potential in patients with venous thromboembolism. J Thromb Thrombolysis. 2023 Aug;56(2):351-354. doi: 10.1007/s11239-023-02836-4. Epub 2023 Jun 10.

  PMID: 37300604 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

gDNA from leucocytes from a biobank (registration number DC-2008-290 and authorization number AC-2008-107)

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: July 3, 2020
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: December 4, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)