Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of AIS Based on Epigene-phenotype

Официальное название

Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of Adolescent Idiopathic Scoliosis Based on Epigene-phenotype

Обзор

Mining AIS biomarkers, elucidating the new mechanism of AIS pathogenicity, constructing risk prediction models, optimizing AIS precise diagnosis and treatment techniques, formulating precise diagnosis and treatment protocols and technical specifications for AIS combined with Chinese and Western medicine with independent intellectual property rights, and realizing the full coverage of Zhejiang Province by the end of 2026, so as to form the "Zhejiang experience" of AIS diagnosis and treatment.

Подробное описание

Currently, there are problems of high genetic and phenotypic heterogeneity in AIS research, lack of in-depth epigenetic studies, and lack of clarity in pathogenic mechanisms. This project proposes to use EWAS technology, combined with a hybrid model of multidimensional and multimodal data fusion, to realize a multi-omics joint analysis, to clarify the amount of synergistic effects between multi-omics risk factors and AIS, to draw a map of modifiable risk factors, to clarify AIS biomarkers, and to reveal AIS To clarify the biomarkers of AIS and reveal the pathogenic mechanism of AIS. Currently, the clinical diagnosis and treatment of AIS is highly subjective and lacks objective and accurate risk prediction, which makes it easy to make wrong clinical decisions, resulting in insufficient, delayed or excessive treatment, missing the optimal time for treatment, and poor clinical efficacy. This project intends to establish a multi-dimensional and multi-modal dynamic database, use the unified model construction technology, combined with the sample imbalance model, to construct a unified and accurate prediction model for AIS, to perform clinical typing and risk stratification for AIS, to establish individualized and accurate diagnostic and treatment protocols for AIS, to improve the efficacy of AIS, to obtain high-quality clinical evidence, and to formulate industry-recognized clinical prevention and treatment standards, norms, and guidelines. Through mining AIS biomarkers, elucidating new mechanisms of AIS pathogenicity, constructing risk prediction models, optimizing AIS precision diagnosis and treatment techniques, and formulating precise diagnosis and treatment protocols and technical specifications for AIS combining Chinese and Western medicine with independent intellectual property rights, the project will achieve full coverage of Zhejiang Province by the end of 2026, forming the "Zhejiang experience" in AIS diagnosis and treatment. Zhejiang experience" will be formed in AIS diagnosis and treatment. The promotion of the results can realize the precision of AIS diagnosis and treatment, improve the efficacy of AIS treatment, reduce the incidence of severe scoliosis, reduce medical expenditure by billions of dollars, and alleviate the economic burden on families and society.

Вмешательства

• Поведенческое Low risk experimental group
  Guiding + Manipulation + Traditional Chinese Medicine
• Поведенческое Medium risk experimental group
  Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces
• Генная терапия High risk experimental group
  Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation
• Поведенческое Control group COBB 10-20°
  Specific Exercise Therapy
• Поведенческое Control group COBB 20-45°
  Orthopedic Braces + Specific Exercise Therapy
• Поведенческое Control group COBB >45°
  Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery
• Другое Experimental group (AIS group)
  Molecular marker exploration and validation
• Другое Control group (healthy control)
  Molecular marker exploration and validation
• Другое Controlled follow-up before and after AIS
  Construction and validation of AIS risk prediction model completed

Первичные конечные точки

• Cobb Angle [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Trunk Rotation Degree -Angle of Trunk Rotation [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Coronal Balance [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Sagittal Balance [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Frontal Convexity Of the Spine Angle [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Offside Convexity Of the Spine Angle [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Electromyographic (AEMG) indicators [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Electroencephalographic (EEG) Index [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Postural Posture Assessment [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]
• Balance Function [Срок оценки: Pre-treatment, 3, 6, 9, 12 months post-treatment]

Критерии участия

Критерии включения

• Patients diagnosed with AIS;② Sex is not limited, age 10-18 years old; ③ Those who sign the informed consent and can cooperate with follow-up visits; ④ Those who can cooperate with X-ray, chemical test, genetic test and other examination and evaluation for the measurement of relevant indexes.

Критерии исключения

• Subjects with spine-related diseases such as Marfan's syndrome;

• Subjects with previous ankylosing spondylitis, spinal neurofibroma, spinal tuberculosis, spinal trauma and other spine-related diseases;

• Subjects with combined serious medical diseases and psychiatric patients;

• Those with ECOG score > 2, which may have an impact on the study results;

• Those who are affected by external factors such as economy, individualized differences, etc., so that they cannot complete the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Prokin balance apparatus — Ханчжоу

Идентификаторы

NCT: NCT06506227 · 2024-KLS-039-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗