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Clinical Trials/NCT05503875
NCT05503875
Recruiting
Not Applicable

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country100 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immunoclassification
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
100
Locations
1
Primary Endpoint
Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis.

Detailed Description

Psoriasis is a heterogeneous condition that can affect skin and other structures. Over the past decade, considerable advances have been made both in our understanding of the pathogenesis of psoriasis and in the revolutionized immunotherapy of its diverse manifestations. Psoriasis heterogeneity and its cutaneous microenvironment is the leading cause of resistance in patients. Novel approaches, including single-cell RNA sequencing technology and CyTOF, are proposed as methodological solutions. By their combination with immunotherapy, we can specifically evaluate the mechanism of psoriasis in the face of immunotherapy agents at the single-cell resolution by detecting the transcriptional activity of cytokines, immune checkpoints, screening neoantigens with high transcription levels, identifying rare cells, and assisting the dissection of the critical immune-metabolic pathways in this complex disease. We aim to improve short-term and long-term precision treatment strategies for patients with psoriasis.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy 5.Informed consent must be obtained 6.For female, ß-hCG test is negative and contraception is accepted

Exclusion Criteria

  • Having severe infections, including hepatitis, HIV and tuberculosis
  • Having significant allergies to biological agents
  • Having a history of malignancy
  • Refusal of contraception
  • Having serious or unstable/uncontrolled illnesses

Outcomes

Primary Outcomes

Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin.

Time Frame: 16 months

The intensity of specific cell subsets will be assessed by flow cytometry in psoriasis patients and healthy controls.

Molecular analysis of psoriasis lesional skin by single-cell RNA sequencing.

Time Frame: 16 months

To analyze the intensity of cytokines or chemokines, such as IL-17, IL-23, TNF in the dermis and epidermis of psoriasis patients

Study Sites (1)

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