Venous ThromboembolismCHIPSNCT04477564
Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2020to 13 Jun 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Venous Thromboembolism
- Keywords
- Clonal Hematopoiesis of indeterminate potential
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unprovoked proximal deep vein thrombosis | Not described | |
| Provoked distal deep vein thrombosis | Not described | |
| age-matched control group with no history of vein thrombosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNMT3A mutations screening
Next generation sequencing
Measured: For sequencing analysis: 2 months
Secondary outcomes (1)
TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening
Next generation sequencing
Measured: For sequencing analysis: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 Jul 2020
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477564
- Sponsor's protocol ID
- NIMAO/2020-01/SB-01
- Acronym
- CHIPS
- Status last verified
- Jun 2023
- First submitted
- 10 Jul 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37300604
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT04477564
- Acronym / sponsor ID
- CHIPS / NIMAO/2020-01/SB-01
- Conditions
- Venous Thromboembolism
- Keywords
- Clonal Hematopoiesis of indeterminate potential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 20 Jul 2020 (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 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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unprovoked proximal deep vein thrombosis | – | – |
| Provoked distal deep vein thrombosis | – | – |
| age-matched control group with no history of vein thrombosis | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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))
Key exclusion criteria (2 listed)
- 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
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
DNMT3A mutations screening
Time frame: For sequencing analysis: 2 months
Next generation sequencing
1 secondary outcome
TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening
Time frame: For sequencing analysis: 2 months
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 4 Dec 2025.
- Results publication: PubMed 37300604Guillotin 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.
- Individual participant dataSharing planned: No
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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. 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, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 2 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 4 Dec 2025. 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?
DNMT3A mutations screening (time frame: For sequencing analysis: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477564, which also lists 1 linked publication.
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 4 Dec 2025.