- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477564
Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism (CHIPS)
June 2, 2023 updated by: Centre Hospitalier Universitaire de Nīmes
Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nîmes, France
- CHU de Nîmes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
Description
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Unprovoked proximal deep vein thrombosis
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Provoked distal deep vein thrombosis
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age-matched control group with no history of vein thrombosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNMT3A mutations screening
Time Frame: For sequencing analysis: 2 months
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Next generation sequencing
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For sequencing analysis: 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening
Time Frame: For sequencing analysis: 2 months
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Next generation sequencing
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For sequencing analysis: 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2020
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
July 10, 2020
First Submitted That Met QC Criteria
July 15, 2020
First Posted (Actual)
July 20, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2020-01/SB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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