Systemic Lupus ErythematosusNCT06294483
Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
An observational study of Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial summary
The present study aims to: Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CBC, Antinuclear Antibody tests (ANA) and Rest of ANA profile
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 30 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. While include In this study as 100 SLE patients will be classified into two groups: Group A: early onset SLE (age at diagnosis \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50 years).
Who may be able to join
- All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Who cannot join
- Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Features, Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
The present study aims to:
Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.
Read the detailed description
This is a cross sectional study, patients with SLE will be gathered from the Internal medicine department and Rheumatology and Immunology outpatient clinic in Sohag university hospital. All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
In this study, 100 SLE patients will be classified into two groups:
Group A: early onset SLE (age at diagnosis \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50
Data collection procedure:
The following clinical data will be collected:
Clinical assessment:
Name, age, gender, smoker or ex-smoker or non-smoker, blood pressure and body mass index.
Clinical manifestations as:
Malar rash. Discoid rash. Photosensitivity. Mucocutaneous or oral ulcer. Alopecia. Raynaud's phenomena. History of deep venous thrombosis. Cutaneous vasculitis. Fever. Lupus nephritis. Arthritis. Myositis. Secondary antiphospholipid syndrome. Serositis. Pleural effusion. Renal manifestations (puffiness and lower limb edema). Neurological (headache, seizers, psychosis and Disturbed conscious level)
Hematological manifestations:
Thrombocytopenia (bleeding tendency) Anemia and Hemolytic anemia (anemic manifestation). Hypertension. Diabetes mellitus. Previous coronary event or Peripheral vascular disease.
Laboratory assessment:
- CBC with differential WBCs count.
- Antinuclear Antibody tests (ANA).
- Anti-double-stranded DNA (ds DNA).
- Anti-Sm.
- C3 and C4 complement level.
- Serum creatinine level.
- Anti phospholipid marker (if needed). Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
The present study aims to:
Compare clinical features, and disease activity as SLEDAI score between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity
Duration of study:
Six months after approval of the protocol by Medical Research Ethics Committee of Sohag faculty of medicine.
Inclusion criteria:
All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Exclusion Criteria:
Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CBC, Antinuclear Antibody tests (ANA), Rest of ANA profile, C3 and C4 complement level., Anti phospholipid marker
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCDiagnostic test
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Antinuclear Antibody tests (ANA)Diagnostic test
To be tool in diagnosis of SLE
Rest of ANA profileDiagnostic test
As tool of diagnosis of SLE
C3 and C4 complement level.Diagnostic test
As method of detection of acute acivity of SLE
Anti phospholipid markerDiagnostic test
To detect antiphospholipid syndrome if there is sign of thrombosis
Serum creatinine and Alb/create ratioDiagnostic test
To detct complication of disease on kidney
2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.Other
Is criteria of diagnosis of SLE
SLEDAI scoresOther
Is score to detect the activity of disease
| Study group | Role | What they receive |
|---|---|---|
| early onset SLE | group of patients diagnosed as SLE before age of fifty years old Receives: Diagnostic Test: CBC; Diagnostic Test: Antinuclear Antibody tests (ANA); Diagnostic Test: Rest of ANA profile; Diagnostic Test: C3 and C4 complement level.; Diagnostic Test: Anti phospholipid marker; Diagnostic Test: Serum creatinine and Alb/create ratio; Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.; Other: SLEDAI scores | |
| late onset SLE | Patients were diagnosed as SLE at age of fifty years old or more Receives: Diagnostic Test: CBC; Diagnostic Test: Antinuclear Antibody tests (ANA); Diagnostic Test: Rest of ANA profile; Diagnostic Test: C3 and C4 complement level.; Diagnostic Test: Anti phospholipid marker; Diagnostic Test: Serum creatinine and Alb/create ratio; Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.; Other: SLEDAI scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the hematological indices as (mean platelet volume) of our SLE patient.
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect mean platelet volume
Measured: for 2 weeks after admission of patient in sohag university hospital]
Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect this neutrophil lymphocyte ratio
Measured: for 2 weeks after admission of patient in sohag university hospital]
Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect platelet lymphocyte ratio
Measured: for 2 weeks after admission of patient in sohag university hospital]
Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
Measured: for 2 weeks after admission of patient in sohag university hospital]
Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.
After detection of previous outcome [ disease activity , clinical feature,haematological indices ] we will compare them to detect the correlation between them for every patient
Measured: for 2 weeks after admission of patient in sohag university hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Jan 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ali kobsy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294483
- Sponsor's protocol ID
- Soh-Med-24-01-09MS
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Features, Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT06294483
- Acronym / sponsor ID
- Soh-Med-24-01-09MS
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 Mar 2024 (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 present study aims to:
Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.
Detailed description
This is a cross sectional study, patients with SLE will be gathered from the Internal medicine department and Rheumatology and Immunology outpatient clinic in Sohag university hospital. All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
In this study, 100 SLE patients will be classified into two groups:
Group A: early onset SLE (age at diagnosis \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50
Data collection procedure:
The following clinical data will be collected:
Clinical assessment:
Name, age, gender, smoker or ex-smoker or non-smoker, blood pressure and body mass index.
Clinical manifestations as:
Malar rash. Discoid rash. Photosensitivity. Mucocutaneous or oral ulcer. Alopecia. Raynaud's phenomena. History of deep venous thrombosis. Cutaneous vasculitis. Fever. Lupus nephritis. Arthritis. Myositis. Secondary antiphospholipid syndrome. Serositis. Pleural effusion. Renal manifestations (puffiness and lower limb edema). Neurological (headache, seizers, psychosis and Disturbed conscious level)
Hematological manifestations:
Thrombocytopenia (bleeding tendency) Anemia and Hemolytic anemia (anemic manifestation). Hypertension. Diabetes mellitus. Previous coronary event or Peripheral vascular disease.
Laboratory assessment:
- CBC with differential WBCs count.
- Antinuclear Antibody tests (ANA).
- Anti-double-stranded DNA (ds DNA).
- Anti-Sm.
- C3 and C4 complement level.
- Serum creatinine level.
- Anti phospholipid marker (if needed). Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
The present study aims to:
Compare clinical features, and disease activity as SLEDAI score between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity
Duration of study:
Six months after approval of the protocol by Medical Research Ethics Committee of Sohag faculty of medicine.
Inclusion criteria:
All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Exclusion Criteria:
Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early onset SLE | – | Diagnostic Test: CBC, Diagnostic Test: Antinuclear Antibody tests (ANA), Diagnostic Test: Rest of ANA profile, Diagnostic Test: C3 and C4 complement level., Diagnostic Test: Anti phospholipid marker, Diagnostic Test: Serum creatinine and Alb/create ratio, Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus., Other: SLEDAI scoresgroup of patients diagnosed as SLE before age of fifty years old |
| late onset SLE | – | Diagnostic Test: CBC, Diagnostic Test: Antinuclear Antibody tests (ANA), Diagnostic Test: Rest of ANA profile, Diagnostic Test: C3 and C4 complement level., Diagnostic Test: Anti phospholipid marker, Diagnostic Test: Serum creatinine and Alb/create ratio, Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus., Other: SLEDAI scoresPatients were diagnosed as SLE at age of fifty years old or more |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. While include In this study as 100 SLE patients will be classified into two groups: Group A: early onset SLE (age at diagnosis \&lt; 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50 years).
Key inclusion criteria (1 listed)
- All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Key exclusion criteria (1 listed)
- Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
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 |
|---|---|---|
| CBCIs used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity | Diagnostic test | early onset SLE, late onset SLE |
| Antinuclear Antibody tests (ANA)To be tool in diagnosis of SLE | Diagnostic test | early onset SLE, late onset SLE |
| Rest of ANA profileAs tool of diagnosis of SLE | Diagnostic test | early onset SLE, late onset SLE |
| C3 and C4 complement level.As method of detection of acute acivity of SLE | Diagnostic test | early onset SLE, late onset SLE |
| Anti phospholipid markerTo detect antiphospholipid syndrome if there is sign of thrombosis | Diagnostic test | early onset SLE, late onset SLE |
| Serum creatinine and Alb/create ratioTo detct complication of disease on kidney | Diagnostic test | early onset SLE, late onset SLE |
| 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.Is criteria of diagnosis of SLE | Other | early onset SLE, late onset SLE |
| SLEDAI scoresIs score to detect the activity of disease | Other | early onset SLE, late onset SLE |
Primary outcome
Evaluate the hematological indices as (mean platelet volume) of our SLE patient.
Time frame: for 2 weeks after admission of patient in sohag university hospital]
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect mean platelet volume
Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.
Time frame: for 2 weeks after admission of patient in sohag university hospital]
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect this neutrophil lymphocyte ratio
Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.
Time frame: for 2 weeks after admission of patient in sohag university hospital]
Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect platelet lymphocyte ratio
Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Time frame: for 2 weeks after admission of patient in sohag university hospital]
Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.
Time frame: for 2 weeks after admission of patient in sohag university hospital
After detection of previous outcome [ disease activity , clinical feature,haematological indices ] we will compare them to detect the correlation between them for every patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Systemic Lupus Erythematosus
Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Active, not recruitingPhase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
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 Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Egypt. 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?
Results are not available in the source record.
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?
Evaluate the hematological indices as (mean platelet volume) of our SLE patient. (time frame: for 2 weeks after admission of patient in sohag university hospital]). The study lists 5 primary outcomes in all. 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 5 Mar 2024.