SLESLE-PROM-MLNCT07890662
Prediction of SLE Flares Using Patient-Reported Outcomes and Machine Learning
An observational study of SLE, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SLE
- What is being tested?
- Patient-Reported Questionnaire (PROs)
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 30 Jun 2027
- 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 to 60 years
- All sexes
- Adult
Study population: This study will include 500 established SLE patients who will recruited from physical medicine, rheumatology and rehabilitation department at sohag university hospital in addition to cairo university hospital.
Who may be able to join
- Age ≥ 18 years. • Both sexes. • Patients diagnosed with SLE who fulfilling the Systemic Lupus 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus (2019 EULAR/ACR SLE classification criteria) • Regular follow up.
Who cannot join
- • Co-existing chronic inflammatory or autoimmune diseases. • Age <18 years • Cognitive impairment. • Incomplete data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, Nasr City
Mohammed Nasrelden, Prof
About this study
This study aims to Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings.
- Conditions
- SLE
- Being tested
- Patient-Reported Questionnaire (PROs)
- Keywords
- SLE, Flare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Questionnaire (PROs)Other
Fatigue, joint pain, morning stiffness, rash, oral ulcers, hair loss, fever, sleep, stress, medication adherence, flare history, patient global assessment (VAS 0-10)
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | This study will include 500 established SLE patients who will recruited from physical medicine, rheumatology and rehabilitation department at sohag university hospital in addition to cairo university hospital. Inclusion criteria: • Age ≥ 18 years. • Both sexes. • Patients diagnosed with SLE who fulfilling the Systemic Lupus 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus (2019 EULAR/ACR SLE classification criteria) • Regular follow up.
Exclusion criteria: • Co-existing chronic inflammatory or autoimmune diseases. • Age <18 years • Cognitive impairment. • Incomplete data. Receives: Other: Patient-Reported Questionnaire (PROs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a low-cost, PRO-based ML tool.
Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start30 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SLEStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alboghdady Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890662
- Sponsor's protocol ID
- Soh-Med-26-6-12MS
- Acronym
- SLE-PROM-ML
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber MRW, Drenkard C, Falasinnu T, Hoi A, Mak A, Kow NY, Svenungsson E, Peterson J, Clarke AE, Ramsey-Goldman R. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3.
PubMed 34345022Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. doi: 10.1136/annrheumdis-2018-214819. Epub 2019 Aug 5.
PubMed 31383717Idborg H, Eketjall S, Pettersson S, Gustafsson JT, Zickert A, Kvarnstrom M, Oke V, Jakobsson PJ, Gunnarsson I, Svenungsson E. TNF-alpha and plasma albumin as biomarkers of disease activity in systemic lupus erythematosus. Lupus Sci Med. 2018 Jun 4;5(1):e000260. doi: 10.1136/lupus-2018-000260. eCollection 2018.
PubMed 29955370Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
PubMed 23754628
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of SLE Flares Using Patient-Reported Outcomes and Machine Learning
- ClinicalTrials.gov ID
- NCT07890662
- Acronym / sponsor ID
- SLE-PROM-ML / Soh-Med-26-6-12MS
- Conditions
- SLE
- Keywords
- SLE, Flare
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Oct 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.
This study aims to Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | Other: Patient-Reported Questionnaire (PROs)This study will include 500 established SLE patients who will recruited from physical medicine, rheumatology and rehabilitation department at sohag university hospital in addition to cairo university hospital. Inclusion criteria: • Age ≥ 18 years. • Both sexes. • Patients diagnosed with SLE who fulfilling the Systemic Lupus 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus (2019 EULAR/ACR SLE classification criteria) • Regular follow up. Exclusion criteria: • Co-existing chronic inflammatory or autoimmune diseases. • Age <18 years • Cognitive impairment. • Incomplete data. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- This study will include 500 established SLE patients who will recruited from physical medicine, rheumatology and rehabilitation department at sohag university hospital in addition to cairo university hospital.
Key inclusion criteria (1 listed)
- Age ≥ 18 years. • Both sexes. • Patients diagnosed with SLE who fulfilling the Systemic Lupus 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus (2019 EULAR/ACR SLE classification criteria) • Regular follow up.
Key exclusion criteria (1 listed)
- • Co-existing chronic inflammatory or autoimmune diseases. • Age <18 years • Cognitive impairment. • Incomplete data.
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 |
|---|---|---|
| Patient-Reported Questionnaire (PROs)Fatigue, joint pain, morning stiffness, rash, oral ulcers, hair loss, fever, sleep, stress, medication adherence, flare history, patient global assessment (VAS 0-10) | Other | SLE patients |
Primary outcome
Develop a low-cost, PRO-based ML tool.
Time frame: 6 months
Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings.
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 22 Oct 2026.
- Background: PubMed 34345022Barber MRW, Drenkard C, Falasinnu T, Hoi A, Mak A, Kow NY, Svenungsson E, Peterson J, Clarke AE, Ramsey-Goldman R. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3.
- Background: PubMed 31383717Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. doi: 10.1136/annrheumdis-2018-214819. Epub 2019 Aug 5.
- Background: PubMed 29955370Idborg H, Eketjall S, Pettersson S, Gustafsson JT, Zickert A, Kvarnstrom M, Oke V, Jakobsson PJ, Gunnarsson I, Svenungsson E. TNF-alpha and plasma albumin as biomarkers of disease activity in systemic lupus erythematosus. Lupus Sci Med. 2018 Jun 4;5(1):e000260. doi: 10.1136/lupus-2018-000260. eCollection 2018.
- Background: PubMed 23754628Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
- 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.
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 SLE, 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: looking for participants now, as of the sponsor's last update on 22 Oct 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 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 Ahmed A. Abdelrahman (+20 11 14585489, Ahmed.Alboghdady@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a low-cost, PRO-based ML tool. (time frame: 6 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 NCT07890662, which also lists 4 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 22 Oct 2026.