Clinical trial NCT06506227: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Cobb Angle
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Trunk Rotation Degree -Angle of Trunk Rotation
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Coronal Balance
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Sagittal Balance
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Frontal Convexity Of the Spine Angle
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Offside Convexity Of the Spine Angle
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Electromyographic (AEMG) indicators
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Electroencephalographic (EEG) Index
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Postural Posture Assessment
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Balance Function
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Questionnaire on Spinal Health of Children and Adolescents
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Skeletal maturity (Risser's sign)
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Types of scoliosis
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Sagittal plane axial distance (SVA)
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Muscle and bone ultrasound
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Number of participants with Chemical testing
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Number of participants with Blood samples
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
measure: Urine test
timeFrame: Pre-treatment, 3, 6, 9, 12 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Prokin balance apparatus
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Jiang Zhong, bachelor
role: STUDY_DIRECTOR
References: