Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening

April 20, 2026 updated by: Beijing Anzhen Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy population, population with hyperlipidemia

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Voluntarily sign the informed consent form

Exclusion Criteria:

  1. Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
  2. Women during pregnancy or breastfeeding
  3. Patients with chronic kidney disease (GFR <60 ml/min) or liver cirrhosis
  4. Individuals unable to cooperate in collecting exhaled breath samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperlipidemia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia
Time Frame: Week1
Week1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2025237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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