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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Yueyang Integrated Medicine Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

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

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: Patients with psoriasis1 intervention
Group B: Non-psoriasis subjects1 intervention

Trial outcomes

Primary outcomes

1

Raman data

Time frame
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

1

Psoriasis Area and Severity Index (PASI)

Time frame
The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoriasis subjects on the 1 day of sample collection.
2

Body Surface Area (BSA)

Time frame
The researcher conducted a Body Surface Area (BSA) assessment on the psoriasis subjects on the 1 day of sample collection.
3

Modified Nail Psoriasis Severity Index (mNAPSI)

Time frame
The researcher conducted a Modified Nail Psoriasis Severity Index (mNAPSI) assessment on the psoriasis subjects on the 1 day of sample collection.
4

Classification of Psoriatic Arthritis (CASPAR)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Yueyang Integrated Medicine Hospital

Lead sponsor

Shanghai 10th People's Hospital

Collaborator

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