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Development and Validation of Classification Criteria for Cutaneous Lupus Erythematosus: A Modified Delphi Method Study and a Multicenter, Multi-source Sample Classification Accuracy Research

Development and Validation of Classification Criteria for Cutaneous Lupus Erythematosus: A Modified Delphi Method Study and a Multicenter, Multi-source Sample Classification Accuracy Research

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107990
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cutaneous lupus erythematosus

Interventions

Gold Standard:Since the final clinical diagnosis based on the classification criteria requires a publicly recognized "gold standard," each case's information is summarized using a (uniformly designed
Index test:The proposed diagnostic index test is a set of classification criteria for various subtypes of cutaneous lupus erythematosus (CLE), including acute CLE (ACLE), subacute CLE (SCLE), discoid

Sponsors

Dermatology Hospital, Chinese Academy of Medical Sciences (Institute of Dermatology, Chinese Academy of Medical Sciences)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Inclusion of lupus patients: Refer to the Asian Dermatological Association (ADA) guidelines for the diagnosis, treatment, and long-term monitoring of cutaneous lupus erythematosus (2021). Patients clinically diagnosed with any type of CLE, based on clinical manifestations and histopathological characteristics, are included. This includes acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and chronic cutaneous lupus erythematosus (CCLE). ACLE can be subdivided into localized and generalized subtypes; SCLE can be subdivided into erythema multiforme-like and papulosquamous subtypes; CCLE can be subdivided into localized discoid lupus erythematosus (DLE), disseminated discoid lupus erythematosus (DDLE), verrucous lupus erythematosus (VLE), tumid lupus erythematosus (TLE), lupus erythematosus profundus (LEP), chilblain lupus erythematosus (CHLE), Blaschko linear lupus erythematosus (BLLE) and Bullous lupus erythematosus(BLE) ; 2.Inclusion of patients for differential diagnosis: Patients diagnosed with non-CLE conditions that need to be differentiated from CLE, ensuring that the control group matches the case group in basic characteristics such as age and gender. The specific diseases for differential diagnosis for each type of CLE patient are as follows (at least five diseases that are most easily confused with each subtype are selected). The inclusion criteria for each disease are based on internationally recognized diagnostic standards for complete clinical confirmation of the disease.

Exclusion criteria

Exclusion criteria: 1. The clinical data is incomplete, making it impossible to comprehensively assess the condition; 2. There is a coexistence of two or more CLE subtypes. Except for VLE and CHLE, which are two subtypes that rarely exist independently, and BLLE and BLE, which are two special CLE subtypes that commonly occur on the basis of a common CLE subtype, the coexistence of at most one other CLE subtype is allowed (the coexistence of two or more other CLE subtypes should be excluded). For cases reported in the literature and those in the previous sample database, the coexistence of other non-CLE diseases is not excluded. For example, patients with overlapping syndromes that meet the diagnostic criteria for CLE are allowed to be included.

Design outcomes

Primary

MeasureTime frame
medical history, symptoms, and physical signs;Hematological laboratory tests;Histopathological features;

Countries

China

Contacts

Public ContactQianjin Lu

Dermatology Hospital, Chinese Academy of Medical Sciences (Institute of Dermatology, Chinese Academy of Medical Sciences)

qianlu5860@pumcderm.cams.cn+86 137 8709 7676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026