Global Longitudinal Health Monitoring and Blood Sample Collection Study to Promote Early-stage Disease Detection and Personalized/Precision Care Using Innovative Research Platforms

NCT07570667 | Not Yet Recruiting

• 1 other identifier: protecting.health/hong kong
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CVD; Type 2 Diabetes; COPD; Cancer; Hypertension

Keywords

Personalized health; Molecular fingerprints; Longitudinal health monitoring; early-stage disease detection; innovative research platforms; Precision care

Outcome Measures

Primary Outcomes (3)

• 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.

  10 years

• 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.

  10 years

• Identification of molecular signatures

  Identify subtle molecular signatures that precede the clinical manifestation of diseases

  10 years

Study Arms (2)

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

High-risk arm

a cohort of 7,500 participants with the presence of cardiovascular risk factors, who are at high risk of contracting selected NCDs

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Signed informed consent form (ICF) of the study.
• Male or female participants.
• Age at Visit 1: 40 years - 70 years.
• 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.
• BMI: 18.5 - 35.0 kg/m\^2.
• Willingness to fill in the study questionnaire.
• Willingness to participate in future visits and medical investigations as defined per protocol.
• Willingness to be followed-up on disease outcome through data linkage to the participant's health-related records.

You may not qualify if:

• Pregnancy at Visit 1 (self-reported, no test required).
• History of HIV, HBV, HCV or HEV infection at Visit 1.
• Vulnerable participants.
• Foreseeable lack of compliance.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Ludwig-Maximilians - University of Munich: collaborator
• Center for Molecular Fingerprinting Research Nonprofit LLC: collaborator

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Neoplasms; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dennis KM Ip, MD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa HC So

CONTACT

(+852) 39176714; haso9150@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 29, 2048
• Study Completion (Estimated): May 29, 2048
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)