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.
Signed informed consent form (ICF) of the study.
Male or female participants.
Age at Visit 1: 40 years - 70 years.
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.
Pregnancy at Visit 1 (self-reported, no test required).
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.
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).
History of HIV, HBV, HCV or HEV infection at Visit 1.
Participants, including both sexes aged 40-70 years at enrollment in Hong Kong. Participants will be assigned to one of two distinct cohorts based on their NCD risk profile: 1. Low-risk arm: a cohort of 7,500 participants with the absence of modifiable cardiovascular risk factors, who are at low risk of contracting selected NCDs, 2. High-risk arm: a cohort of 7,500 participants with the presence of cardiovascular risk factors, who are at high risk of contracting selected Those who are deemed preliminarily eligible will be scheduled for an initial study visit at a designated study site (e.g., Phase 1 Clinical Trials Unit, The University of Hong Kong) for screening, consenting and enrolment procedures.
Cohort
Prospective
Not listed
Establish Personalized Molecular Baselines
Longitudinal blood sampling from participants in a healthy state (i.e., free from NCDs) will allow comparison between the intra- and inter-individual stability of thousands of molecular variables. Stable molecular signatures will be defined within their personalized reference range, which characterizes an individual's current health state.
Establishment of Health Screening Algorithm
Create an AI-driven health screening tool for predicting diseases based on personalized molecular profiles and health parameters. This algorithm will be made to find early signs of disease before clinical symptoms show up by looking for any deviations from an individual's personalized molecular baseline.
Identification of molecular signatures
Identify subtle molecular signatures that precede the clinical manifestation of diseases
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The University of Hong Kong
Lead sponsor
Center for Molecular Fingerprinting Research Nonprofit LLC
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
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