NCT06790940Not yet recruiting
Construction of a Psoriasis and Psoriatic Arthritis Diagnostic Model Based on Multidimensional Nail Information
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 310 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06790940
What you commit to
- Study type: Observational
- Planned participants: 310
- From 20 Jan 2025 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- Patients whom the researchers deem unsuitable for participation in this study for other reasons.
- Patients whom the researchers deem unsuitable for participation in this study for other reasons.
Who the study is looking for
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- 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.
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Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.