HealthNCT07569094
Research Plan for Early Disease Screening Biomarkers in Healthy Individuals
An observational study of Health, run by Zhonghao Fang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy populations
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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 |
|---|---|---|
| Health | healthy populations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood routine test
Measured: At the time of enrollment
Secondary outcomes (2)
Liver function
Measured: At the time of enrollment
renal function
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhonghao Fang
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor-investigator, Zhonghao Fang, Guangzhou Medical University
- Investigators
- Zifeng Yang, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569094
- Sponsor's protocol ID
- P-2026-002
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to concerns over patient privacy and confidentiality issues, the individual patient data (IPD) cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Plan for Early Disease Screening Biomarkers in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07569094
- Acronym / sponsor ID
- P-2026-002
- Conditions
- Health
- Keywords
- health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhonghao FangUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health | – | –healthy populations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy populations
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Blood routine test
Time frame: At the time of enrollment
2 secondary outcomes
Liver function
Time frame: At the time of enrollment
renal function
Time frame: At the time of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Due to concerns over patient privacy and confidentiality issues, the individual patient data (IPD) cannot be shared.
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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.
Zifeng Yang study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health, run by Zhonghao Fang at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Peng, Doctor (86-020-85959142, pl_206@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood routine test (time frame: At the time of enrollment). 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 6 May 2026.