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

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Prokin balance apparatus — Hangzhou

Identifiers

NCT: NCT06506227 · 2024-KLS-039-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗