Vascular ComplicationsICI-VascNCT07535944
Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors
An observational study of Vascular Complications, run by University Hospital, Rouen at 1 site in France.
Trial summary
The development of immune checkpoint inhibitors (ICIs) has revolutionized the management of many oncological diseases, and their use continues to increase. ICIs are monoclonal antibodies that target immune checkpoints such as PD-1 (programmed cell death protein 1, as seen in nivolumab, pembrolizumab, and cemiplimab)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Complications
- What is being tested?
- Evaluation of the vascular impact of ICIs (Immune Checkpoint Inhibitors)
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jun 2031
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with an Immune Checkpoint Inhibitor (ICI) as monotherapy (curative or as an adjunct to surgery) or a combination of ICIs in the dermatology oncology department
Who may be able to join
- Patient treated with an ICI (nivolumab, pembrolizumab, atezolizumab, ipilimumab, cemiplima, or any novel antibody directed against PD-1, PD-L1, CTLA-4, or LAG-3) as monotherapy or in combination with another ICI or with radiotherapy,
- Patient over 18 years of age,
- WHO performance status: 0 to 2,
- Oral informed consent,
- Patient affiliated with or beneficiary of a social security scheme.
Who cannot join
- History of ICI treatment,
- History of chemotherapy or targeted therapy within the last 4 weeks,
- Stage 4 PAD,
- Severe Raynaud's syndrome,
- Removal of both hands and/or both feet,
- Removal of the right hand/left foot or the left hand/right foot,
Show all 9Show fewer
- Patient deprived of liberty by an administrative or judicial decision or patient under legal protection, guardianship, or curatorship,
- Pregnant or breastfeeding woman,
- Patient unable to understand the study for any reason or to comply with the trial requirements (language barrier, psychological, geographical, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de ROUEN
Rouen, 76031
Jeremy Bellien, Pr, 02 32 88 14 28, jeremy.bellien@chu-rouen.fr
Jeremy Bellien, Pr
About this study
Official title: Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors in Cancer Treatment: a Multidimensional Study of a Patient Cohort
The development of immune checkpoint inhibitors (ICIs) has revolutionized the management of many oncological diseases, and their use continues to increase. ICIs are monoclonal antibodies that target immune checkpoints such as PD-1 (programmed cell death protein 1, as seen in nivolumab, pembrolizumab, and cemiplimab), PD-L1 (programmed cell death protein 1 ligand, as seen in atezolizumab, avelumab, and durvalumab), CTLA-4 (cytotoxic T-lymphocyte antigen 4, as seen in ipilimumab and tremelimumab), or LAG-3 (lymphocyte-activating gene 3, as seen in relatlimab), which play a crucial role in immune tolerance to cancer cells.
However, the surge in ICI prescriptions has been accompanied by the occurrence of numerous side effects, some of which are severe or even fatal. ICIs have a different toxicity spectrum than conventional chemotherapy, and most toxicities result from excessive immunity against different organs.
Read more
This immune-mediated toxicity can affect various organ systems, including the heart and blood vessels. Pharmacovigilance data from clinical trials conducted by Bristol-Myers Squibb, which marketed ipilimumab (anti-CTLA-4) and nivolumab (anti-PD1), revealed 18 cases (0.09%) of myocarditis among 20,594 subjects.
While cardiac complications induced by immune checkpoint inhibitors (ICIs), particularly autoimmune myocarditis, are widely described, the impact of these treatments on the vascular system remains poorly understood. However, a variety of vascular complications have been reported, ranging from vasculitis of large, medium, and small vessels to a possible increase in arterial thrombotic events, ischemic strokes, and acute coronary syndromes.
The incidence of vasculitis appears to be between 1% and 2% of patients treated with immune checkpoint inhibitors (ICIs). This is emerging as a significant signal in various pharmacovigilance studies, suggesting the involvement of immune checkpoint derepression in the pathophysiology of vasculitis. A translational study demonstrated the major role of CTLA-4 in the pathophysiology of giant cell arteritis (GCA), although the precise mechanisms involved remain to be determined. Therefore, a specific immune environment could promote the development of vasculitis, a phenomenon reproduced by ICI administration.
The increase in arterial thrombotic vascular events was primarily observed in a matched cohort study, which showed a threefold increased risk of arterial thrombotic vascular events following the initiation of ICI therapy. These thrombotic events would coincide with the acceleration of atherosclerosis in patients treated with ICIs. This "accelerated" atherosclerosis could be linked to inflammatory changes within the plaques, causing plaque destabilization or rupture. It is also unreasonable to rule out the possibility that the accelerated atherosclerosis is related to the development of vasculitis in these patients.
Read the detailed description
The various mechanisms involved in vascular complications during ICI therapy could be responsible for early vascular toxicity in the aorta and its main branches, characterized by increased stiffness. This increased arterial stiffness, indicative of premature vascular aging and leading to impaired cardiocirculatory coupling, could be accompanied by subsequent cardiovascular events, or even predictive of immunological complications, even though short-term ICI use does not appear to be associated with the development of hypertension.
Thus, the extent of vascular complications induced by ICIs, the mechanisms involved, as well as the progression of vascular damage and the associated long-term consequences after treatment discontinuation in patients in remission, remain poorly understood. In particular, the hypothesis of this research is that an increase in arterial stiffness is induced very rapidly by ICIs due to immune modifications and that the persistence of this increase in stiffness after stopping treatment is associated with an increased cardiovascular risk in patients.
Given the increasing use of immune checkpoint inhibitors (ICIs) and the number of patients treated, a better understanding of the vascular impact of these drugs is both necessary and urgent.
The results obtained should allow us to determine, for the first time, the vascular impact of ICIs, as well as to identify the immunological mechanisms involved and the long-term prognosis consequences for patients due to potential premature arterial aging induced by ICI treatment. This is a multidisciplinary clinical-biological research study involving the Clinical Pharmacology Department for vascular investigations, the Clinical Investigation Center (CIC-CRB 1404) for biological sampling, and the Dermatology Department (Dr. Janela) for volunteer recruitment and follow-up.
This cohort study will also be combined with pharmacoepidemiological and pharmacovigilance studies using the French National and International Pharmacovigilance Databases (BNPV and VigiBase) (Dr. Nathalie Massy). On the other hand, experimental studies will be conducted in murine models of vascular pathologies within the UMR Inserm 1096 EnVI (Dr. Antoine Hérault's PhD thesis, supervised by Professor Fabienne Tamion, Dr. Dominique Modovar and Dr. Ebba Brakenhielm) in order to better understand the role of ICIs in vascular pathophysiology and ultimately be able to propose care and/or treatments adapted to patients receiving ICIs in order to prevent or limit their adverse effects including deleterious cardiovascular consequences.
- Conditions
- Vascular Complications
- Being tested
- Evaluation of the vascular impact of ICIs (Immune Checkpoint Inhibitors)
- Keywords
- immune checkpoint inhibitors, cancer therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the vascular impact of ICIs (Immune Checkpoint Inhibitors)Other
A multidisciplinary clinical-biological approach to research involving the clinical pharmacology department for the creation of the popmeter (population pharmacokinetic/pharmacodynamic analysis tool), the CIC-CRB1404 for the management of biological samples, the dermatology oncology department (Dr. Raphael Janela) for the recruitment and monitoring of volunteers, and the Inserm U1096 EnVI laboratory for the measurement of lymphocyte and monocyte activation markers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is an increase in aortic arterial stiffness 6 to 8 weeks after the start of ICI treatment.
Evaluation of the variation in pulse wave velocity (PWV) measured by photoplethysmography (Popmeter®, Axelife) between the initial value and the value after 6 to 8 weeks of ICI treatment.
Measured: 8 weeks
Secondary outcomes (29)
Determine if there is an increase in aortic arterial stiffness one year after the start of ICI treatment
Evaluation of the change in PVO measured by photoplethysmography (Popmeter®, Axelife) between the initial value and the value after 1 year of ICI treatment
Measured: 1 year
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of brachial arterial pressures by photoplethysmography (Popmeter)
Measured: 8 weeks
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of brachial arterial pressures by photoplethysmography (Popmeter)
Measured: 1 year
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of aortic pressures by photoplethysmography (Popmeter)
Measured: 8 weeks
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of aortic augmentation index by photoplethysmography (Popmeter)
Measured: 8 weeks
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of aortic pressures by photoplethysmography (Popmeter)
Measured: 1 year
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Evaluation of aortic augmentation index by photoplethysmography (Popmeter)
Measured: 1 year
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Determine if there is a link between overall and progression-free survival and ICI treatment at 1 year
Measured: 1 year
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Determine if there is a link between overall and progression-free survival and ICI treatment at 2 years
Measured: 2 years
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Determine if there is a link between overall and progression-free survival and ICI treatment at 3 years.
Measured: 3 years
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Determine if there is a link between the occurrence of cardiac and vascular complications and treatment with ICI at 6-8 weeks
Measured: 8 weeks
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Determine if there is a link between the occurrence of cardiac and vascular complications and treatment with ICI at 1 year
Measured: 1 year
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Determine if there is a link between the occurrence of cardiac and vascular complications and treatment with ICI at 2 years
Measured: 2 years
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Determine if there is a link between the occurrence of cardiac and vascular complications and treatment with ICI at 3 years.
Measured: 3 years
Increase in pro- or anti-inflammatory plasma cytokines (IL-1)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (IL-1)
Measured: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-6)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (IL-6)
Measured: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-10)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (IL-10)
Measured: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-17)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (IL-17)
Measured: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines ( TNF-α)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (TNF-α)
Measured: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IFN-γ)
Measurement of plasma concentrations of pro- or anti-inflammatory cytokines (IFN-γ)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD3)
Determination of the expression of lymphocyte and monocyte markers (CD3)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD4)
Determination of the expression of lymphocyte and monocyte markers (CD4)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD8)
Determination of the expression of lymphocyte and monocyte markers (CD8)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD44)
Determination of the expression of lymphocyte and monocyte markers (CD44)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD62L)
Determination of the expression of lymphocyte and monocyte markers (CD62L)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (HLA-DR)
Determination of the expression of lymphocyte and monocyte markers (HLA-DR)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD69)
Determination of the expression of lymphocyte and monocyte markers (CD69)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD14)
Determination of the expression of lymphocyte and monocyte markers (CD14)
Measured: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD16)
Determination of the expression of lymphocyte and monocyte markers (CD16)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy JB BELLIEN, Professor, Principal investigator, Univerity Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535944
- Sponsor's protocol ID
- 2025/0494/OB
- Other IDs
- 2026-A00192-49
- Acronym
- ICI-Vasc
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors in Cancer Treatment: a Multidimensional Study of a Patient Cohort
- ClinicalTrials.gov ID
- NCT07535944
- Acronym / sponsor ID
- ICI-Vasc / 2025/0494/OB
- Conditions
- Vascular Complications
- Keywords
- immune checkpoint inhibitors, cancer therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 17 Apr 2026 (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 development of immune checkpoint inhibitors (ICIs) has revolutionized the management of many oncological diseases, and their use continues to increase. ICIs are monoclonal antibodies that target immune checkpoints such as PD-1 (programmed cell death protein 1, as seen in nivolumab, pembrolizumab, and cemiplimab), PD-L1 (programmed cell death protein 1 ligand, as seen in atezolizumab, avelumab, and durvalumab), CTLA-4 (cytotoxic T-lymphocyte antigen 4, as seen in ipilimumab and tremelimumab), or LAG-3 (lymphocyte-activating gene 3, as seen in relatlimab), which play a crucial role in immune tolerance to cancer cells.
However, the surge in ICI prescriptions has been accompanied by the occurrence of numerous side effects, some of which are severe or even fatal. ICIs have a different toxicity spectrum than conventional chemotherapy, and most toxicities result from excessive immunity against different organs.
This immune-mediated toxicity can affect various organ systems, including the heart and blood vessels. Pharmacovigilance data from clinical trials conducted by Bristol-Myers Squibb, which marketed ipilimumab (anti-CTLA-4) and nivolumab (anti-PD1), revealed 18 cases (0.09%) of myocarditis among 20,594 subjects.
While cardiac complications induced by immune checkpoint inhibitors (ICIs), particularly autoimmune myocarditis, are widely described, the impact of these treatments on the vascular system remains poorly understood. However, a variety of vascular complications have been reported, ranging from vasculitis of large, medium, and small vessels to a possible increase in arterial thrombotic events, ischemic strokes, and acute coronary syndromes.
The incidence of vasculitis appears to be between 1% and 2% of patients treated with immune checkpoint inhibitors (ICIs). This is emerging as a significant signal in various pharmacovigilance studies, suggesting the involvement of immune checkpoint derepression in the pathophysiology of vasculitis. A translational study demonstrated the major role of CTLA-4 in the pathophysiology of giant cell arteritis (GCA), although the precise mechanisms involved remain to be determined. Therefore, a specific immune environment could promote the development of vasculitis, a phenomenon reproduced by ICI administration.
The increase in arterial thrombotic vascular events was primarily observed in a matched cohort study, which showed a threefold increased risk of arterial thrombotic vascular events following the initiation of ICI therapy. These thrombotic events would coincide with the acceleration of atherosclerosis in patients treated with ICIs. This "accelerated" atherosclerosis could be linked to inflammatory changes within the plaques, causing plaque destabilization or rupture. It is also unreasonable to rule out the possibility that the accelerated atherosclerosis is related to the development of vasculitis in these patients.
Detailed description
The various mechanisms involved in vascular complications during ICI therapy could be responsible for early vascular toxicity in the aorta and its main branches, characterized by increased stiffness. This increased arterial stiffness, indicative of premature vascular aging and leading to impaired cardiocirculatory coupling, could be accompanied by subsequent cardiovascular events, or even predictive of immunological complications, even though short-term ICI use does not appear to be associated with the development of hypertension.
Thus, the extent of vascular complications induced by ICIs, the mechanisms involved, as well as the progression of vascular damage and the associated long-term consequences after treatment discontinuation in patients in remission, remain poorly understood. In particular, the hypothesis of this research is that an increase in arterial stiffness is induced very rapidly by ICIs due to immune modifications and that the persistence of this increase in stiffness after stopping treatment is associated with an increased cardiovascular risk in patients.
Given the increasing use of immune checkpoint inhibitors (ICIs) and the number of patients treated, a better understanding of the vascular impact of these drugs is both necessary and urgent.
The results obtained should allow us to determine, for the first time, the vascular impact of ICIs, as well as to identify the immunological mechanisms involved and the long-term prognosis consequences for patients due to potential premature arterial aging induced by ICI treatment. This is a multidisciplinary clinical-biological research study involving the Clinical Pharmacology Department for vascular investigations, the Clinical Investigation Center (CIC-CRB 1404) for biological sampling, and the Dermatology Department (Dr. Janela) for volunteer recruitment and follow-up.
This cohort study will also be combined with pharmacoepidemiological and pharmacovigilance studies using the French National and International Pharmacovigilance Databases (BNPV and VigiBase) (Dr. Nathalie Massy). On the other hand, experimental studies will be conducted in murine models of vascular pathologies within the UMR Inserm 1096 EnVI (Dr. Antoine Hérault's PhD thesis, supervised by Professor Fabienne Tamion, Dr. Dominique Modovar and Dr. Ebba Brakenhielm) in order to better understand the role of ICIs in vascular pathophysiology and ultimately be able to propose care and/or treatments adapted to patients receiving ICIs in order to prevent or limit their adverse effects including deleterious cardiovascular consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with an Immune Checkpoint Inhibitor (ICI) as monotherapy (curative or as an adjunct to surgery) or a combination of ICIs in the dermatology oncology department
Key inclusion criteria (5 listed)
- Patient treated with an ICI (nivolumab, pembrolizumab, atezolizumab, ipilimumab, cemiplima, or any novel antibody directed against PD-1, PD-L1, CTLA-4, or LAG-3) as monotherapy or in combination with another ICI or with radiotherapy,
- Patient over 18 years of age,
- WHO performance status: 0 to 2,
- Oral informed consent,
- Patient affiliated with or beneficiary of a social security scheme.
Key exclusion criteria (9 listed)
- History of ICI treatment,
- History of chemotherapy or targeted therapy within the last 4 weeks,
- Stage 4 PAD,
- Severe Raynaud's syndrome,
- Removal of both hands and/or both feet,
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 |
|---|---|---|
| Evaluation of the vascular impact of ICIs (Immune Checkpoint Inhibitors)A multidisciplinary clinical-biological approach to research involving the clinical pharmacology department for the creation of the popmeter (population pharmacokinetic/pharmacodynamic analysis tool), the CIC-CRB1404 for the management of biological samples, the dermatology oncology department (Dr. Raphael Janela) for the recruitment and monitoring of volunteers, and the Inserm U1096 EnVI laboratory for the measurement of lymphocyte and monocyte activation markers. | Other | – |
Primary outcome
Determine if there is an increase in aortic arterial stiffness 6 to 8 weeks after the start of ICI treatment.
Time frame: 8 weeks
Evaluation of the variation in pulse wave velocity (PWV) measured by photoplethysmography (Popmeter®, Axelife) between the initial value and the value after 6 to 8 weeks of ICI treatment.
29 secondary outcomes
Determine if there is an increase in aortic arterial stiffness one year after the start of ICI treatment
Time frame: 1 year
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 8 weeks
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 1 year
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 8 weeks
Determine if there are, 6 to 8 weeks after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 8 weeks
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 1 year
Determine if there are one year after the start of ICI treatment: An alteration in systemic hemodynamics and cardiocirculatory coupling,
Time frame: 1 year
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Time frame: 1 year
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Time frame: 2 years
Llink between overall and progression-free survival and ICI treatment at 1 year, 2 years and 3 years.
Time frame: 3 years
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Time frame: 8 weeks
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Time frame: 1 year
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Time frame: 2 years
Link between the occurrence of cardiac and vascular complications and treatment with ICI
Time frame: 3 years
Increase in pro- or anti-inflammatory plasma cytokines (IL-1)
Time frame: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-6)
Time frame: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-10)
Time frame: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IL-17)
Time frame: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines ( TNF-α)
Time frame: 8 weeks
Increase in pro- or anti-inflammatory plasma cytokines (IFN-γ)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD3)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD4)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD8)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD44)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD62L)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (HLA-DR)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD69)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD14)
Time frame: 8 weeks
Modification of the level of lymphocyte and monocyte activation (CD16)
Time frame: 8 weeks
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 10 Jun 2026.
- 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.
Jérémy JB BELLIEN, Professor principal investigator
Univerity Rouen Hospital
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 Vascular Complications, run by University Hospital, Rouen 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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?
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 Nabila NL LAAJAIL, Director (02 32 88 82 65 ext. +33, Nabila.Laajail@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is an increase in aortic arterial stiffness 6 to 8 weeks after the start of ICI treatment. (time frame: 8 weeks). 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 10 Jun 2026.