Global Longitudinal Health Monitoring and Blood Sample Collection Study to Promote Early-stage Disease Detection and Personalized/Precision Care Using Innovative Research Platforms
Trial ID: NCT07570667
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-05-01
Completion date: 2048-05-29
Sponsor: The University of Hong Kong
Collaborators: Center for Molecular Fingerprinting Research Nonprofit LLC; Ludwig-Maximilians - University of Munich
Conditions: CVD; Type 2 Diabetes; COPD; Cancer; Hypertension
Locations: School of Public Health, The University of Hong Kong
Countries: Hong Kong
Enrollment: 15000
Age range: 40 Years - 70 Years
Sex: ALL

Summary:
The investigators propose a prospective, longitudinal, observational study to improve health assessment by analyzing blood plasma molecular patterns in each individual over time using artificial intelligence (AI) to identify key measurements for early detection of NCDs. It will develop personalized reference ranges and screening methods, laying the foundation for population-based early detection. This study focus on collecting health data and biospecimen samples to understand early molecular changes linked to disease.

Eligibility criteria:
Inclusion Criteria:

1. Signed informed consent form (ICF) of the study.
2. Male or female participants.
3. Age at Visit 1: 40 years - 70 years.
4. For Low-risk Arm: Assessed as healthy (free of acute or chronic disease) with no cardiovascular risk conditions listed in Inclusion criteria 5. Participants may have mild disorders that do not require regular therapeutic (pharmacological) intervention; For High-risk Arm: Assessed as healthy (free of acute or chronic diseases) with cardiovascular risk conditions listed in Inclusion criteria 5. Participant may have mild disorders that do not require regular therapeutic (pharmacological) intervention.
5. For Low-risk Arm: Has low risk to contract an NCD in the upcoming years, according to the following criteria: a) Non-hypertensive person according to criteria of the relevant national guideline, who never received antihypertensive medication; b) Total cholesterol: \< 5.2 mmol/L (\<200 mg/dL) with no history of lipid-lowering (e.g., statin) treatment; c) Non smoker or with no significant smoking history (\<5 pack-years); For High-risk Arm: Has high risk to contract an NCD in the upcoming years, confirmed by the presence of at least 2 out of the following 3 criteria (a, b, c): a) Medically controlled hypertension: participants with diagnosed hypertension receiving antihypertensive medication ; b) Medically controlled dyslipidemia or hypercholesterolemia: participants with diagnosed dyslipidemia or hypercholesterolemia receiving lipid-lowering medication; c) Significant smoking history (tobacco exposure of \>20 pack-years) and/or 1st degree family member with history of lung cancer.
6. BMI: 18.5 - 35.0 kg/m\^2.
7. Willingness to fill in the study questionnaire.
8. Willingness to participate in future visits and medical investigations as defined per protocol.
9. Willingness to be followed-up on disease outcome through data linkage to the participant's health-related records.

Exclusion Criteria:

1. Pregnancy at Visit 1 (self-reported, no test required).
2. For low-risk arm: Past medical history (PMH) of target NCDs, any other significant health conditions, clinical symptoms, abnormalities of blood parameters or medical tests suggesting the presence of abnormal health conditions at Visit 1. Any condition that is inadequately controlled. The sponsor should be contacted for advice in case of any uncertainties; For high-risk arm: Except for the conditions mentioned under inclusion criteria (point 5a and b), participants with PMH of target NCDs, any other health conditions, clinical symptoms, abnormalities of blood parameters or medical tests suggesting the presence of abnormal health conditions at Visit 1 are excluded from the study. Any condition that is inadequately controlled. Sponsor should be contacted for advice in case of any uncertainties.
3. For low-risk arm: Any chronic, systemic drug therapy at Visit 1 (prescription); For high-risk arm: Any chronic, systemic drug therapy at Visit 1 except for conditions mentioned under Inclusion criteria (point 5a and b).
4. History of HIV, HBV, HCV or HEV infection at Visit 1.
5. Vulnerable participants.
6. Foreseeable lack of compliance.

Outcomes:
Establish Personalized Molecular Baselines; Establishment of Health Screening Algorithm; Identification of molecular signatures