Childhood AsthmaNCT04525586
lncRNA-based Nomogram to Assist Childhood Asthma Diagnosis
An observational study of Childhood Asthma, run by Children's Hospital of Fudan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Childhood Asthma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with recurrent wheezing who apply to Department of Respiratory Medicine, Children's Hospital of Fudan University.
Who may be able to join
- children with recurrent wheezing
Who cannot join
- diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
- immunodeficiency- acquired or congenital
- neuromuscular disease
- congenital heart disease
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| It's just an observational study, no interventions | children with recurrent wheezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start31 Dec 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liling Qian, PhD., Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525586
- Sponsor's protocol ID
- LLJ1.0
- Status last verified
- Dec 2022
- First submitted
- 21 Aug 2020
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LncRNA and Predictive Model to Improve the Early Diagnosis of Childhood Asthma
- ClinicalTrials.gov ID
- NCT04525586
- Acronym / sponsor ID
- LLJ1.0
- Conditions
- Childhood Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| It's just an observational study, no interventions | – | –children with recurrent wheezing |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with recurrent wheezing who apply to Department of Respiratory Medicine, Children's Hospital of Fudan University.
Key inclusion criteria (1 listed)
- children with recurrent wheezing
Key exclusion criteria (4 listed)
- diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
- immunodeficiency- acquired or congenital
- neuromuscular disease
- congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of early diagnosis of childhood asthma
Time frame: 24 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liling Qian, PhD. study director
Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Asthma, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of early diagnosis of childhood asthma (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.