ClinicalTrials.Veeva

Menu

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

T

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status

Not yet enrolling

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Behavioral: Medium risk experimental group
Other: Controlled follow-up before and after AIS
Behavioral: Control group COBB 20-45°
Other: Experimental group (AIS group)
Behavioral: Low risk experimental group
Behavioral: Control group COBB >45°
Other: Control group (healthy control)
Behavioral: Control group COBB 10-20°
Genetic: High risk experimental group

Study type

Interventional

Funder types

Other

Identifiers

NCT06506227
2024-KLS-039-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2,000 participants in 2 patient groups

according to the order of their visits then were assigned numbers
Experimental group
Description:
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.
Treatment:
Genetic: High risk experimental group
Behavioral: Control group COBB 10-20°
Other: Control group (healthy control)
Behavioral: Control group COBB >45°
Other: Experimental group (AIS group)
Behavioral: Low risk experimental group
Behavioral: Control group COBB 20-45°
Other: Controlled follow-up before and after AIS
Behavioral: Medium risk experimental group
According to the order of their visits to the clinic, given the appropriate number,
Experimental group
Description:
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.
Treatment:
Genetic: High risk experimental group
Behavioral: Control group COBB 10-20°
Other: Control group (healthy control)
Behavioral: Control group COBB >45°
Other: Experimental group (AIS group)
Behavioral: Low risk experimental group
Behavioral: Control group COBB 20-45°
Other: Controlled follow-up before and after AIS
Behavioral: Medium risk experimental group

Trial contacts and locations

1

Loading...

Central trial contact

Jiang Zhong, bachelor; Honggen Du, bachelor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems