Research Plan for Early Disease Screening Biomarkers in Healthy Individuals

NCT07569094 | Not Yet Recruiting

• 1 other identifier: P-2026-002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health

Keywords

health

Outcome Measures

Primary Outcomes (1)

• Blood routine test

  At the time of enrollment

Secondary Outcomes (2)

• Liver function

  At the time of enrollment

• renal function

  At the time of enrollment

Other Outcomes (3)

• Transcriptomics

  At the time of enrollment

• Proteomics

  At the time of enrollment

• Metagenome

  At the time of enrollment

Study Arms (1)

Health

healthy populations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy populations

You may qualify if:

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

You may not qualify if:

• 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);
• Pregnant or lactating women;
• Recent (within 3 months) history of surgery, trauma or blood transfusion;
• Mental illness or cognitive impairment that makes it impossible to cooperate with the research.

Sponsors & Collaborators

• Zhonghao Fang: lead
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and deep sputum

Study Officials

• Zifeng Yang

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Liang Peng, Doctor

CONTACT

86-020-85959142; pl_206@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)