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RecruitingNCT07890662SLE-PROM-MLUpdated Oct 22, 2026

Prediction of SLE Flares Using Patient-Reported Outcomes and Machine Learning

An observational study in SLE, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 3 months later.
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • SLE

Keywords

  • SLE
  • Flare
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.

Browse Sohag University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Co-existing chronic inflammatory or autoimmune diseases. • Age \<18 years • Cognitive impairment. • Incomplete data.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Patient-Reported Questionnaire (PROs)

Interventions

  • OtherPatient-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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sohag University
    Sohag, Nasr City, Egypt
    • Mohammed Nasrelden, Prof · Contact
    Recruiting
08

References and documents

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 34345022 ↗
  • Aringer 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 31383717 ↗
  • Idborg 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 29955370 ↗
  • Petri 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 22, 2026
StartActual
Jun 30, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890662
Lead sponsor
Sohag University
Responsible party
Ahmed Alboghdady Abdelrahman (Dr, Sohag University) — Principal investigator
First posted
Oct 22, 2026
Start date
Jun 30, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Ahmed A. Abdelrahman
Contact
Ahmed.Alboghdady@med.sohag.edu.eg
+20 11 14585489
Sohag University
Contact
Ahmed.Alboghdady@med.sohag.edu.eg
+20 11 14585489

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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