Systemic Lupus ErythematosusNCT06404723
The Predictive and Prognostic Values of the Fibrinogen to Albumin Ratio and C-reactive Protien to Albumin Ratio in Systemic Lupus Erythematosus Patients
An observational study of Systemic Lupus Erythematosus, run by Sohag University.
Trial summary
The aim of the study was to study the predictive value of FAR and CAR in order to provide a new predictive biomarkers for the disease activity and prognosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Apr 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 150 participants were included in a Case-Control study: 1. Healthy control group: this group contains 50 healthy individual. 2. Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15. 3. Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.
Who may be able to join
- Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with
- ≥18 years of age.
- Complete clinical and laboratory investigations.
- No concomitant infection, systemic or other autoimmune diseases.
Who cannot join
- Patients were excluded from the study if they had any of the following:
- <18 years of age,
- Incomplete clinical data and laboratory indicators.
- End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2
- Patients with:
- Acute infectious diseases, HIV infection carriers,
- Concomitant systemic diseases such as chronic obstructive lung disease, coronary artery disease, cancer, thyroid function disorder, hematological disorders, acute or chronic liver and renal diseases.
- Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, or primary Sjogren's syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study was to study the predictive value of FAR and CAR in order to provide a new predictive biomarkers for the disease activity and prognosis.
Read the detailed description
A total of 150 participants were included in a Case-Control study:
- Healthy control group: this group contains 50 healthy individual.
- Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15.
- Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.
Setting:
This study will be conducted to All patients will enter to The Rheumatology Department, Sohag University Hospital for one year.
Inclusion criteria:
Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with
- ≥18 years of age.
- Complete clinical and laboratory investigations.
- No concomitant infection, systemic or other autoimmune diseases.
Exclusion criteria:
Patients were excluded from the study if they had any of the following:
- <18 years of age,
- Incomplete clinical data and laboratory indicators.
- End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2
- Patients with:
- Acute infectious diseases, HIV infection carriers,
- Concomitant systemic diseases such as chronic obstructive lung disease, coronary artery disease, cancer, thyroid function disorder, hematological disorders, acute or chronic liver and renal diseases.
- Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, or primary Sjogren's syndrome.
Methods:
All patients will be subjected to the following:
- Thorough medical history from the patients
- Full clinical examination including:
- General examination and vital signs.
- Complete rheumatological examination.
- Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score.
- Laboratory examinations include:
- Complete blood picture (CBC). 2. Erythrocyte sedimentation rate (ESR). 3. C-reactive protein (CRP) 4. Liver function tests (LFT). 5. Renal investigations:
- Kidney functions
- Urine analysis
- 24 hours protein in urine and/or A/C ratio or p/c ratio.
- eGFR
- Renal biopsy. 6. ANA by IF. 4. Specific tests: a. Fibrinogen to Albumin ratio (FAR). b. C-Reactive protein to Albumin Ratio (CAR).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio
- 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.
Fibrinogen to albumin Ratio and C-reactive to Albumin RatioDiagnostic test
to detect their relation to disease activity to use as predective and prognostic tools
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | : this group contains 50 healthy individual Receives: Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio | |
| Lupus Simplex (mild to moderate disease) activity Group | this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15. Receives: Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio | |
| Severe disease activity Group | this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15. Receives: Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrinogen/Albumin ratio, C-reactive protein /Albumin ratio
detect if the results approve their use as a predictive and prognostic tools for SLE
Measured: 1-6-2024 to 1-6-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (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.
- More trials run by Sohag UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Gamal Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404723
- Sponsor's protocol ID
- soh-Med-24-02-07MD
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive and Prognostic Values of the Fibrinogen to Albumin Ratio and C-reactive Protien to Albumin Ratio in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06404723
- Acronym / sponsor ID
- soh-Med-24-02-07MD
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 8 May 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 aim of the study was to study the predictive value of FAR and CAR in order to provide a new predictive biomarkers for the disease activity and prognosis.
Detailed description
A total of 150 participants were included in a Case-Control study:
- Healthy control group: this group contains 50 healthy individual.
- Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15.
- Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.
Setting:
This study will be conducted to All patients will enter to The Rheumatology Department, Sohag University Hospital for one year.
Inclusion criteria:
Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with
- ≥18 years of age.
- Complete clinical and laboratory investigations.
- No concomitant infection, systemic or other autoimmune diseases.
Exclusion criteria:
Patients were excluded from the study if they had any of the following:
- <18 years of age,
- Incomplete clinical data and laboratory indicators.
- End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2
- Patients with:
- Acute infectious diseases, HIV infection carriers,
- Concomitant systemic diseases such as chronic obstructive lung disease, coronary artery disease, cancer, thyroid function disorder, hematological disorders, acute or chronic liver and renal diseases.
- Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, or primary Sjogren's syndrome.
Methods:
All patients will be subjected to the following:
- Thorough medical history from the patients
- Full clinical examination including:
- General examination and vital signs.
- Complete rheumatological examination.
- Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score.
- Laboratory examinations include:
- Complete blood picture (CBC). 2. Erythrocyte sedimentation rate (ESR). 3. C-reactive protein (CRP) 4. Liver function tests (LFT). 5. Renal investigations:
- Kidney functions
- Urine analysis
- 24 hours protein in urine and/or A/C ratio or p/c ratio.
- eGFR
- Renal biopsy. 6. ANA by IF. 4. Specific tests: a. Fibrinogen to Albumin ratio (FAR). b. C-Reactive protein to Albumin Ratio (CAR).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio: this group contains 50 healthy individual |
| Lupus Simplex (mild to moderate disease) activity Group | – | Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratiothis group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15. |
| Severe disease activity Group | – | Diagnostic Test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratiothis group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 150 participants were included in a Case-Control study: 1. Healthy control group: this group contains 50 healthy individual. 2. Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15. 3. Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.
Key inclusion criteria (4 listed)
- Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with
- ≥18 years of age.
- Complete clinical and laboratory investigations.
- No concomitant infection, systemic or other autoimmune diseases.
Key exclusion criteria (8 listed)
- <18 years of age,
- Incomplete clinical data and laboratory indicators.
- End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2
- Patients with:
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 |
|---|---|---|
| Fibrinogen to albumin Ratio and C-reactive to Albumin Ratioto detect their relation to disease activity to use as predective and prognostic tools | Diagnostic test | Healthy Control Group, Lupus Simplex (mild to moderate disease) activity Group, Severe disease activity Group |
Primary outcome
Fibrinogen/Albumin ratio, C-reactive protein /Albumin ratio
Time frame: 1-6-2024 to 1-6-2025
detect if the results approve their use as a predictive and prognostic tools for SLE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Sohag University.
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 4 inclusion and 8 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Manar G Mohammed, spcialist (+2 01069191994, manar_gamal_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrinogen/Albumin ratio, C-reactive protein /Albumin ratio (time frame: 1-6-2024 to 1-6-2025). 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 8 May 2024.