Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lipid Abnormality Mass Spectrometry Screening Model.
- Who it may be relevant to
- Registry conditions: Hyperlipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for screening abnormal blood lipids, and explores a simple, fast, and non-invasive method for screening abnormal blood lipids.
Interventions
- Diagnostic test Lipid Abnormality Mass Spectrometry Screening Model
By analyzing the lipid profile in human breath, explore a simple, fast, and non-invasive method for screening dyslipidemia
Primary outcome measures
- Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia [Time frame: Week1]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Voluntarily sign the informed consent form
Exclusion criteria
- Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
- Women during pregnancy or breastfeeding
- Patients with chronic kidney disease (GFR <60 ml/min) or liver cirrhosis
- Individuals unable to cooperate in collecting exhaled breath samples
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07546162 · KS2025237