Research Plan for Early Disease Screening Biomarkers in Healthy Individuals

April 28, 2026 updated by: Zhonghao Fang
The establishment of reference intervals for biomarkers in healthy populations relies on large-scale, standardized cohort data. However, current baseline data for hematology, liver and kidney function, and multi-omics (genomics, transcriptomics, proteomics, and metabolomics) in Chinese healthy populations are constrained by significant regional disparities and insufficient sample sizes, limiting the development of early disease screening markers. To address these challenges, this study aims to: (1) establish a comprehensive database for hematology and liver/kidney function indicators; (2) construct a multi-omics database using blood and sputum samples; and (3) explore the correlations among multi-omics indicators and their associations with demographic characteristics.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

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

  • Name: Liang Peng, Doctor
  • Phone Number: 86-020-85959142
  • Email: pl_206@126.com

Study Locations

  • China
      • Guangzhou, China
        • Fifth Affiliated Hospital of Guangzhou Medical University

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 populations

Description

Inclusion Criteria:

  1. Age: 18 - 65 years old, gender not restricted;
  2. No clear history of chronic diseases (hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic liver and kidney diseases, tumors, etc.);
  3. No infection history in the past 3 months (fever, cough, sore throat, etc.);
  4. No use of antibiotics, hormones, immunosuppressants, etc. within the past 1 month;
  5. Voluntarily sign the informed consent form and cooperate to complete the follow-up.

Exclusion Criteria:

  1. Abnormal laboratory indicators (ALT/AST > 2 times the upper limit of normal value, Cr > upper limit of normal value, main indicators of blood routine test are abnormal and have clinical significance);
  2. Pregnant or lactating women;
  3. Recent (within 3 months) history of surgery, trauma or blood transfusion;
  4. Mental illness or cognitive impairment that makes it impossible to cooperate with the research.

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
Health
healthy populations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood routine test
Time Frame: At the time of enrollment
At the time of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver function
Time Frame: At the time of enrollment
At the time of enrollment
renal function
Time Frame: At the time of enrollment
At the time of enrollment

Other Outcome Measures

Outcome Measure
Time Frame
Transcriptomics
Time Frame: At the time of enrollment
At the time of enrollment
Proteomics
Time Frame: At the time of enrollment
At the time of enrollment
Metagenome
Time Frame: At the time of enrollment
At the time of enrollment

Collaborators and Investigators

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

Sponsor

Zhonghao Fang

Collaborators

Fifth Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Director: Zifeng Yang, The First Affiliated Hospital of Guangzhou Medical University

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)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-2026-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to concerns over patient privacy and confidentiality issues, the individual patient data (IPD) cannot be shared.

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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