MedTrace Logo

OMERACT SLE Delphi

NCT07136090 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-08-22

No results posted yet for this study

Summary

SLE is a chronic multi-systemic autoimmune disease with clinical manifestations characterized by recurrent flares in disease activity and damage in several organs. SLE affects primarily women during child bearing age and is negatively related to productivity, social role participation and health-related quality of life. The multi-systemic nature of SLE and its diverse clinical manifestations have led to many outcome measurements being utilized in SLE clinical trials and longitudinal studies. To standardize measurement in clinical trials and longitudinal studies, the OMERACT SLE Group developed the core domain set for SLE in 1998. A core domain set is a set of outcome measures, capturing all the facets/aspects of the disease, that standardizes measurement and research across clinical trials and longitudinal studies necessary for the advancement of the field. Since development in 1998, many new important domains for SLE have been identified, thus there is an unmet need to update the core domain set. A new OMERACT SLE Working Group has been established to update the SLE core domain set.

This is a qualitative study that aims to prioritize domains to include in the SLE core domain set. All participants will be asked to complete a four-round online survey. During rounds 1-3 participants will be asked to rate the importance of each domain to be included; round 4 will ask participants select and rank domains. Participants will also have the option of adding other items or descriptors and to provide any other feedback. Each round of the survey will take approximately 15-20 minutes to complete.

Participants will need to participate in round 1 in order to be invited to round 2, and then participate in round 2 in order to be invited to round 3, and final participate in round 3 in order to be invited to round 4.

Conditions

  • SLE - Systemic Lupus Erythematosus

Sponsors & Collaborators

  • OMERACT

    collaborator UNKNOWN

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Zahi Touma, MD, PhD · University Health Network and University of Toronto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-10-31
Completion
2025-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136090 on ClinicalTrials.gov