Juvenile Systemic Lupus ErythematosusNCT06718283
Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients:Correlation With Disease Activity and Chronic Organ Damage in These Patients
An observational study of Juvenile Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial summary
The study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Systemic Lupus Erythematosus
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 2 Feb 2026
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Patients males or females below age of 18 years diagnosed as juvenile systemic lupus erythematosus based on 2012 SLICC criteria or 2019 ACR/EULAR criteria
Who may be able to join
- patients who fillful 2012 SLICC criteria or 2019 ACR/EULAR criteria of systemic lupus erythematosus
- Age of patients at disease onset before 18 years
Who cannot join
- Adult onset disease ( age at disease onset after 18 years
- Any other chronic inflamatory disorders or other autoimmune diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Esam M Abualfadl contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Sohag
Alshimaa H Khalaf, Assistant lecturer, 01067790054, elshimaa011054@med.sohag.edu.eg
Esam M Abualfadl, Professor, 01123977966
About this study
Official title: Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients : Correlation With Disease Activity and Chronic Organ Damage in These Patients
The study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index
Read the detailed description
We calculate important hematologic indices in children diagnosed as SLE as systemic inflamatory index ,systemic inflamatory response index and aggregate index of systemic inflamation in these patients ,and correlate these indices with SLE disease activity index and chronic damage index in these patients.
- Conditions
- Juvenile Systemic Lupus Erythematosus
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of hematological indices in juvenile lupus erythematosus patients
Calculation of systemic inflamatory index,systemic information response index and aggregate index of systemic inflamation ,and correlate these indices to SLE disease activity index
Measured: 3_ 6 months
Correlation between hematologic indices in juvenile lupus erythematosus patients and disease activity in these patients
SLEDAI score in juvenile lupus erythematosus patients
Measured: 3-6 months
Secondary outcomes (2)
Calculation of chronic damage index in juvenile lupus erythematosus patients
SLICC/ACR score in juvenile lupus erythematosus patients
Measured: 3_6 months
Relationship between hematologic index and chronic organ damage index in juvenile lupus erythematosus patients
SLICC/ACR score
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start30 Nov 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Juvenile 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshimaa Hamdey Khalaf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718283
- Sponsor's protocol ID
- Soh-Med-24-11_3MD
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aringer M, Petri M. New classification criteria for systemic lupus erythematosus. Curr Opin Rheumatol. 2020 Nov;32(6):590-596. doi: 10.1097/BOR.0000000000000740.
PubMed 32925250Liu P, Li P, Peng Z, Xiang Y, Xia C, Wu J, Yang B, He Z. Predictive value of the neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-neutrophil ratio, and neutrophil-to-monocyte ratio in lupus nephritis. Lupus. 2020 Aug;29(9):1031-1039. doi: 10.1177/0961203320929753. Epub 2020 Jun 5.
PubMed 32501169Hassan MR, Hossain A, Mahata J, Srivastava V, Sarkar S. Hematological manifestation of Pediatric Systemic Lupus Erythematosus (SLE) - A single centered cross-sectional study. J Family Med Prim Care. 2024 May;13(5):1787-1792. doi: 10.4103/jfmpc.jfmpc_1583_23. Epub 2024 May 24.
PubMed 38948621
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients : Correlation With Disease Activity and Chronic Organ Damage in These Patients
- ClinicalTrials.gov ID
- NCT06718283
- Acronym / sponsor ID
- Soh-Med-24-11_3MD
- Conditions
- Juvenile Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 5 Dec 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 study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index
Detailed description
We calculate important hematologic indices in children diagnosed as SLE as systemic inflamatory index ,systemic inflamatory response index and aggregate index of systemic inflamation in these patients ,and correlate these indices with SLE disease activity index and chronic damage index in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients males or females below age of 18 years diagnosed as juvenile systemic lupus erythematosus based on 2012 SLICC criteria or 2019 ACR/EULAR criteria
Key inclusion criteria (2 listed)
- patients who fillful 2012 SLICC criteria or 2019 ACR/EULAR criteria of systemic lupus erythematosus
- Age of patients at disease onset before 18 years
Key exclusion criteria (2 listed)
- Adult onset disease ( age at disease onset after 18 years
- Any other chronic inflamatory disorders or other autoimmune diseases
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
Calculation of hematological indices in juvenile lupus erythematosus patients
Time frame: 3_ 6 months
Calculation of systemic inflamatory index,systemic information response index and aggregate index of systemic inflamation ,and correlate these indices to SLE disease activity index
Correlation between hematologic indices in juvenile lupus erythematosus patients and disease activity in these patients
Time frame: 3-6 months
SLEDAI score in juvenile lupus erythematosus patients
2 secondary outcomes
Calculation of chronic damage index in juvenile lupus erythematosus patients
Time frame: 3_6 months
Relationship between hematologic index and chronic organ damage index in juvenile lupus erythematosus patients
Time frame: 3-6 months
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 5 Dec 2024.
- Background: PubMed 32925250Aringer M, Petri M. New classification criteria for systemic lupus erythematosus. Curr Opin Rheumatol. 2020 Nov;32(6):590-596. doi: 10.1097/BOR.0000000000000740.
- Background: PubMed 32501169Liu P, Li P, Peng Z, Xiang Y, Xia C, Wu J, Yang B, He Z. Predictive value of the neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-neutrophil ratio, and neutrophil-to-monocyte ratio in lupus nephritis. Lupus. 2020 Aug;29(9):1031-1039. doi: 10.1177/0961203320929753. Epub 2020 Jun 5.
- Background: PubMed 38948621Hassan MR, Hossain A, Mahata J, Srivastava V, Sarkar S. Hematological manifestation of Pediatric Systemic Lupus Erythematosus (SLE) - A single centered cross-sectional study. J Family Med Prim Care. 2024 May;13(5):1787-1792. doi: 10.4103/jfmpc.jfmpc_1583_23. Epub 2024 May 24.
- 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.
Esam M Abualfadl contact
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 Juvenile 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 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: looking for participants now, as of the sponsor's last update on 5 Dec 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?
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 Alshimaa H Khalaf (01067790054, elshimaa011054@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of hematological indices in juvenile lupus erythematosus patients (time frame: 3_ 6 months). The study lists 2 primary outcomes in all. 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 NCT06718283, which also lists 3 linked publications.
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 Dec 2024.