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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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according to the order of their visits then were assigned numbers

The patients were assigned numbers according to the order of their visits, and after obtaining informed consent, they were divided into a treatment group and a control group to conduct a prospective cohort study.

Group Type EXPERIMENTAL

Low risk experimental group

Intervention Type BEHAVIORAL

Guiding + Manipulation + Traditional Chinese Medicine

Medium risk experimental group

Intervention Type BEHAVIORAL

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces

High risk experimental group

Intervention Type GENETIC

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation

Control group COBB 10-20°

Intervention Type BEHAVIORAL

Specific Exercise Therapy

Control group COBB 20-45°

Intervention Type BEHAVIORAL

Orthopedic Braces + Specific Exercise Therapy

Control group COBB >45°

Intervention Type BEHAVIORAL

Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery

Experimental group (AIS group)

Intervention Type OTHER

Molecular marker exploration and validation

Control group (healthy control)

Intervention Type OTHER

Molecular marker exploration and validation

Controlled follow-up before and after AIS

Intervention Type OTHER

Construction and validation of AIS risk prediction model completed

According to the order of their visits to the clinic, given the appropriate number,

According to the order of their visits to the clinic, given the appropriate number, divided into the test group and the control group, in strict accordance with the results of the group, the appropriate treatment and observation of the group, the teams of personnel and the implementation of clinical treatment should not be the same person.

Group Type EXPERIMENTAL

Low risk experimental group

Intervention Type BEHAVIORAL

Guiding + Manipulation + Traditional Chinese Medicine

Medium risk experimental group

Intervention Type BEHAVIORAL

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces

High risk experimental group

Intervention Type GENETIC

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation

Control group COBB 10-20°

Intervention Type BEHAVIORAL

Specific Exercise Therapy

Control group COBB 20-45°

Intervention Type BEHAVIORAL

Orthopedic Braces + Specific Exercise Therapy

Control group COBB >45°

Intervention Type BEHAVIORAL

Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery

Experimental group (AIS group)

Intervention Type OTHER

Molecular marker exploration and validation

Control group (healthy control)

Intervention Type OTHER

Molecular marker exploration and validation

Controlled follow-up before and after AIS

Intervention Type OTHER

Construction and validation of AIS risk prediction model completed

Interventions

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Low risk experimental group

Guiding + Manipulation + Traditional Chinese Medicine

Intervention Type BEHAVIORAL

Medium risk experimental group

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces

Intervention Type BEHAVIORAL

High risk experimental group

Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation

Intervention Type GENETIC

Control group COBB 10-20°

Specific Exercise Therapy

Intervention Type BEHAVIORAL

Control group COBB 20-45°

Orthopedic Braces + Specific Exercise Therapy

Intervention Type BEHAVIORAL

Control group COBB >45°

Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery

Intervention Type BEHAVIORAL

Experimental group (AIS group)

Molecular marker exploration and validation

Intervention Type OTHER

Control group (healthy control)

Molecular marker exploration and validation

Intervention Type OTHER

Controlled follow-up before and after AIS

Construction and validation of AIS risk prediction model completed

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes