lncRNA-based Nomogram to Assist Childhood Asthma Diagnosis

LncRNA and Predictive Model to Improve the Early Diagnosis of Childhood Asthma

Asthma is the most common chronic disease in children, however, underdiagnosis of childhood asthma is an important issue in asthma management. The lack of reliable and objective diagnostic indicators requires the development of rapid and accurate strategies for the early diagnosis of childhood asthma. Recent studies have found a correlation between long-chain non-coding RNA (lncRNA) expression and childhood asthma, suggesting that lncRNA may be a potential biomarker for asthma diagnosis.

Study Overview

• Status: Withdrawn
• Conditions: Childhood Asthma

Detailed Description

The investigators envision exploring the early diagnosis of asthma by combining lncRNA with electronic medical records. In this project, the investigators will combine high-throughput sequencing, asthma case database, electronic medical record and informatics to investigate the feasibility of combining lncRNA with electronic medical record for asthma diagnostic model. The expected results will establish the foundation for the diagnosis and treatment of childhood asthma and open up new ideas.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with recurrent wheezing who apply to Department of Respiratory Medicine, Children's Hospital of Fudan University.

Description

Inclusion Criteria:

children with recurrent wheezing

Exclusion Criteria:

1. diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
2. immunodeficiency- acquired or congenital
3. neuromuscular disease
4. congenital heart disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
It's just an observational study, no interventions; children with recurrent wheezing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of early diagnosis of childhood asthma	a diagnosis of transient wheeze or asthma was made by a pediatric pulmonologist. This classification was based on symptoms, use of asthma medication, and lung function features.	24 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Liling Qian, PhD., Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: LLJ1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.

Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No