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Набор скоро начнётся NCT06579976

Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index

— Наблюдательное Plaque Psoriasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Plaque Psoriasis. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index：a Prospective Cohort Study

Обзор

Psoriasis (PsO) is a common chronic relapsing inflammatory disease, induced by a combination of genetic and environmental effects, which seriously affects the quality of life of patients.Psoriasis Area and Severity Index（PASI score ） ，as the most common method used by clinicians to assess the severity of psoriasis and the effectiveness of treatment, has the disadvantage of being subjective and superficial.We are therefore committed to establishing an objective, real-time, repeatable, non-invasive, microscopic assessment using high-frequency ultrasound. This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months.

Подробное описание

High-frequency ultrasound (HFUS) with a center frequency of more than 10 MHz, and a resolution of 16-158 μm. The detailed detection items are epidermal thickness (unit mm), dermal thickness (unit mm), hypoechoic cord thickness between epidermis and dermis (unit mm), epidermal echo intensity, dermal echo intensity, clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound; blood flow signal (pcs) detected by Color Doppler imaging and Power doppler imaging. The 8 tests will be detected the skin lesions and 2cm beside skin lesions area.Based on the correlation between the 8 indexes and local PASI scores, we will establish a model for the evaluation of psoriasis by multimodal high-frequency ultrasound.This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months

Вмешательства

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

Первичные конечные точки

  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Срок оценки: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
Вторичные конечные точки (1)
  • Localized PASI [Срок оценки: Measurement of the patient's lesion areas were taken once 1 day]

Критерии участия

Критерии включения

  • Patients who meet the medical criteria for plaque psoriasis
  • Those who voluntarily participate in this study and sign the informed consent form

Критерии исключения

  • Patients with other types of psoriasis
  • Those with other active medical conditions that may affect assessment
  • During a severe uncontrollable acute or chronic local or systemic infection
  • Those with severe mental illness, cognitive impairment, and incapacity for personal behavior that makes them unsuitable to participate in a clinical study
  • Other reasons the investigator considers unsuitable for participation in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Shanghai Yueyang Integrated Medicine Hospital — Шанхай

Идентификаторы

NCT: NCT06579976 · 20230701

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗