Construction of a Psoriasis and Psoriatic Arthritis Diagnostic Model Based on Multidimensional Nail Information

NCT06790940 | Not Yet Recruiting

• 1 other identifier: 224-243
• Study Type: observational
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief Summary

Psoriasis is a globally prevalent chronic relapsing skin disease, characterized by its long duration and tendency to relapse. In addition to skin symptoms, it can also affect nails and joints, leading to pathological features such as pitting, leukonychia, red lunula, or severe nail dystrophy. Some patients with psoriasis may develop psoriatic arthritis. Psoriatic arthritis (PsA) is a chronic relapsing musculoskeletal disease, characterized by psoriatic skin lesions accompanied by axial and peripheral joint damage, and often associated with characteristic manifestations of psoriatic nails. These nail changes typically indicate more severe disease and poorer prognosis. However, current diagnostic methods largely depend on the experience and professional knowledge of clinicians, which are subjective and uncertain. Moreover, histopathological examination is invasive and can cause additional pain and inconvenience to patients. To develop an effective, convenient, and non-invasive early diagnostic tool for psoriasis, our research team has conducted in-depth studies in the field of psoriasis-related diagnosis and predictive models. We have successfully developed a predictive model for psoriatic arthritis, including six key predictive factors: history of joint swelling, history of arthritis, history of swelling and pain in fingers or toes, nail involvement, genital involvement, and a history of long-term local use of corticosteroids. Clinicians can effectively assess the risk of psoriatic arthritis by obtaining information about these six factors from patients. The paper "Early detection of psoriatic arthritis in patients with psoriasis: construction of a multifactorial prediction model" was published in Front. Immunol (DOI: 10.3389/fimmu.2024.1426127). Raman spectroscopy is a rapid, non-invasive molecular vibration detection method that has shown great potential in medical diagnostics. Studies have shown that Raman spectroscopy can distinguish normal and abnormal tissues at the molecular level and has been proven feasible in nail testing. For psoriasis, a disease that causes significant nail changes, Raman spectroscopy offers unique advantages. Based on this background, our project will conduct a prospective observational study on psoriasis and psoriatic arthritis using multidimensional nail data. We will integrate Raman spectroscopy data of nails and multidimensional clinical information and apply artificial intelligence algorithms to develop a new diagnostic tool for psoriasis and psoriatic arthritis. This tool aims to improve the accuracy and efficiency of diagnosis, providing strong support for the early detection and precise treatment of psoriasis and psoriatic arthritis.

Conditions

Psoriasis (PsO); Psoriatic Arthritis; Palmoplantar Pustulosis (PPP); Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Raman data

  1 day (The collected nail samples will be placed on aluminum-coated slides for Raman spectroscopic analysis, and the Raman peak data will be exported to form a txt file.)

Secondary Outcomes (4)

• Psoriasis Area and Severity Index (PASI)

  The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoriasis subjects on the 1 day of sample collection.

• Body Surface Area (BSA)

  The researcher conducted a Body Surface Area (BSA) assessment on the psoriasis subjects on the 1 day of sample collection.

• Modified Nail Psoriasis Severity Index (mNAPSI)

  The researcher conducted a Modified Nail Psoriasis Severity Index (mNAPSI) assessment on the psoriasis subjects on the 1 day of sample collection.

• Classification of Psoriatic Arthritis (CASPAR)

  The researcher conducted a Classification of Psoriatic Arthritis (CASPAR) assessment on the psoriasis subjects on the 1 day of sample collection.

Study Arms (2)

Patients with psoriasis

Other: No intervention

Non-psoriasis subjects

Other: No intervention

Interventions

No intervention OTHER

This is an observational study, no intervention will be implemented.

Non-psoriasis subjects; Patients with psoriasis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study plans to select and include 155 patients with psoriasis from those visiting the Department of Dermatology at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, as the experimental group. Additionally, 155 patients who visit for non-psoriasis skin conditions such as eczema or acne, and have been professionally diagnosed and confirmed by doctors not to have psoriasis, will be chosen as the control group.

You may qualify if:

• Previous or first-time diagnosis o psoriasis; if previously diagnosed, no restrictions on prior treatments;
• Age ≥ 18 and ≤ 80 years, with no gender restrictions;
• Consent to participate in this study and sign an informed consent form.
• (1) Patients who visit for other non-psoriasis skin conditions such as eczema or acne, and are confirmed by dermatologists not to have psoriasis; (3) Age ≥ 18 and ≤ 80 years, with no gender restrictions; (4) Consent to participate in this study and sign an informed consent form.

You may not qualify if:

• Those with unsuitable nail conditions for collection: patients with amputated fingers due to trauma or other reasons, and patients with any nail that is severely broken and cannot be effectively collected.
• Patients with severe mental illness or cognitive impairment, lacking personal decision-making capacity, and unsuitable for participation in clinical research.
• Patients with severe systemic diseases.
• Patients with a history of malignant tumors, as well as those with primary or secondary immunodeficiency and hypersensitivity.
• Patients whom the researchers deem unsuitable for participation in this study for other reasons.
• Those with unsuitable nail conditions for collection: patients with amputated fingers due to trauma or other reasons, and patients with any nail that is severely broken and cannot be effectively collected.
• Patients with severe mental illness or cognitive impairment, lacking personal decision-making capacity, and unsuitable for participation in clinical research.
• Patients with severe systemic diseases.
• Patients with a history of malignant tumors, as well as those with primary or secondary immunodeficiency and hypersensitivity.
• Patients whom the researchers deem unsuitable for participation in this study for other reasons.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• Shanghai 10th People's Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

The samples collected are nail segments from all fingers of the participants. Specifically, the samples are 1-2 millimeter segments excised from the distal edge of the nail plate, which is located at the terminal part of the nail body and serves as the border connecting the nail bed to the fingertip.

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

Xin Li Doctor

CONTACT

13661956326; 13661956326@163.com

Qingyun Wang Miss

CONTACT

18251339800; WqySci@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01