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Standardization and Multicenter, Large-Scale Clinical Application of Point-of-Care Testing (POCT) Technologies for Major Chronic Diseases

Standardization and Multicenter, Large-Scale Clinical Application of Point-of-Care Testing (POCT) Technologies for Major Chronic Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117291
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Atherosclerotic Heart Disease

Interventions

Gold Standard:Assay results from routine central clinical laboratories (such as the quantification of biomarkers like Troponin and CRP via chemiluminescence or electrochemical techniques) or definitiv
Index test:CHD: Heart failure-related protein biomarkers (eg. Troponin)
COPD: Disease-related inflammatory protein biomarkers (eg. IL-6, CRP)
CRC: Protein and nucleic acid tumor markers (eg. CEA)
Diabetes: Protein biomarkers associated with diabetic complications (eg. Creatinine).

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Coronary Atherosclerotic Heart Disease 1. Aged 40 to 75 years (inclusive). 2. Meets the clinical diagnostic criteria for coronary heart disease: Coronary angiography indicates significant atherosclerotic lesions (luminal stenosis >50%). 3.Serum or plasma samples are preserved in the established biobank of the research unit, or consent is provided for the collection of residual serum or plasma samples from clinical diagnosis and treatment. Chronic Obstructive Pulmonary Disease 1. Aged 40 to 75 years (inclusive). 2. Meets the clinical diagnostic criteria for COPD: Pulmonary function testing showing post-bronchodilator FEV1/FVC = 7.0 mmol/L; or random blood glucose >= 11.1 mmol/L; or 2-hour blood glucose >= 11.1 mmol/L during an Oral Glucose Tolerance Test (OGTT); or Glycated Hemoglobin (HbA1c) > 6.5%. 3. Prediabetes: Fasting venous blood glucose between 6.1 and 6.9 mmol/L; AND 2-hour blood glucose between 7.8 and 11.0 mmol/L during an OGTT; or HbA1c between 5.7% and 6.4%. 4. Serum or plasma samples are preserved in the established biobank of the research unit, or consent is provided for the collection of residual serum or plasma samples from clinical diagnosis and treatment.

Exclusion criteria

Exclusion criteria: Coronary Atherosclerotic Heart Disease 1. Participated in other clinical trials within 30 days prior to enrollment. 2. Presence of severe heart failure caused by cardiac valvular dysfunction or severe arrhythmia. 3. Comorbid with or suspected of having systemic embolic diseases, such as pulmonary embolism or severe deep vein thrombosis of the lower extremities. 4. History of surgical trauma or severe trauma within the past 1 month, including hemorrhagic diseases, cerebral infarction, etc. 5. History of undergoing percutaneous coronary intervention (stenting) or surgical bypass grafting. 6. Pregnant or planning a pregnancy. 7.Lacking the capacity for autonomous conduct or unable to understand the research process, and having no legal representative. 8. Incomplete clinical data. Chronic Obstructive Pulmonary Disease 1. Participated in other clinical trials within 30 days prior to enrollment. 2. Other clinical diseases that may cause obstructive ventilatory dysfunction, including active tuberculosis, lung transplantation, etc. 3. Lacking the capacity for autonomous conduct or unable to understand the research process, and having no legal representative. 4. Incomplete clinical data. 5.Women who are pregnant or lactating. Colorectal Cancer 1.Participated in other clinical trials within 30 days prior to enrollment. 2.Women who are pregnant or lactating. 3.History of malignancy and corresponding treatment history. 4. Received blood transfusion within 30 days prior to blood collection. 5. History of organ, bone marrow, or stem cell transplantation. 6.Health condition unsuitable for blood collection. 7. Incomplete clinical data. 8. Lacking the capacity for autonomous conduct or unable to understand the research process, and having no legal representative. 9. Other diseases deemed unsuitable for the study by the investigator. Diabetes Mellitus 1. Participated in other clinical trials within 30 days prior to enrollment. 2. Lacking the capacity for autonomous conduct or unable to understand the research process, and having no legal representative. 3. Incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Incidence of adverse events;Negative Predictive Value;Positive Predictive Value;Disease control rate (DCR);Specificity;Objective response rate (ORR);

Countries

China

Contacts

Public ContactRui Zhang

Beijing Hospital

ruizhang@nccl.org.cn+86 10 58115053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026