- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07595094
Phenotypic Age Acceleration (PhenoAgeAccel) for Joint Prediction of Disease Risk, Mortality Risk, Life Expectancy, and Disease-Free Healthspan in Major Chronic Diseases
The goal of this observational study is to learn about the ability of Phenotypic Age Acceleration (PhenoAgeAccel) to predict four key health outcomes in Chinese people with or at risk of major chronic diseases: the risk of developing new chronic diseases, the risk of dying, life expectancy, and disease-free healthspan.
The main questions this study aims to answer are:
- Does higher PhenoAgeAccel increase the risk of developing major chronic diseases (including diabetes, dementia, cancer, and chronic respiratory diseases) in Chinese adults?
- Does higher PhenoAgeAccel increase the risk of death from all causes in Chinese adults?
- How do life expectancy and disease-free healthspan differ between people with high versus low PhenoAgeAccel?
Who can take part in this study? Adults aged 35 or above years old who receive routine care at participating hospitals in China, have complete routine blood test data available, and have provided consent to use their health information for research purposes.
What will participants go through? Participants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. We will collect data from their medical records, including blood test results used to calculate PhenoAgeAccel, diagnoses of new diseases, and dates of death.
What are the potential benefits? Participants will not receive direct personal benefits from taking part in this study. However, the information learned may help us better understand biological aging and improve future risk assessment and health management for people with chronic diseases.
Is this study safe? Yes. This is an observational study that does not involve any new drugs, devices, or invasive procedures. All data used in the study will be de-identified and kept strictly confidential to protect participants' privacy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xi-jian Dai, Doctor
- Número de teléfono: 13755756959
- Correo electrónico: daixjdoctor@126.com
Ubicaciones de estudio
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- Reclutamiento
- Second Affiliated Hospital of Nanchang University
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Contacto:
- Xi-Jian Dai Xi-Jian Dai, MD
- Número de teléfono: +86-137-5575-6959
- Correo electrónico: daixjdoctor@126.com
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Contacto:
- Correo electrónico: daixjdoctor@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged 35-73 years old. Complete routine blood test data available at baseline to calculate Phenotypic -Age (including albumin, alkaline phosphatase, creatinine, glucose, C-reactive protein, lymphocyte percentage, mean corpuscular volume, red cell distribution width, and white blood cell count).
Complete demographic and clinical data (e.g., sex, BMI, comorbidities) available at baseline.
- Consent to use routine medical data for research follow-up analysis.
Exclusion Criteria:
- Presence of end-stage diseases (e.g., end-stage liver/renal failure) other than the major chronic diseases of interest at baseline.
- Key baseline data missing, making Phenotypic Age calculation impossible. Incomplete follow-up information or inability to confirm outcomes (e.g., death, disease onset) via database linkage.
- Refusal to participate in the study or withdrawal of informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Non-accelerated PhenoAge Group
Participants with normal biological aging, defined as Phenotypic Age Acceleration ≤ 0. No study-specific intervention is administered; all participants receive routine clinical care as usual.
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This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
|
Mildly Accelerated PhenoAge Group
Participants with mild biological aging acceleration, defined as 0 < Phenotypic Age Acceleration < median.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
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This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
|
Severely Accelerated PhenoAge Group
Participants with severe biological aging acceleration, defined as Phenotypic Age Acceleration ≥ median.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Major Chronic Diseases
Periodo de tiempo: Baseline through study completion, average 10 years
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Composite incidence of new-onset major chronic diseases, including type 2 diabetes, dementia, cancer, and chronic respiratory diseases, defined by ICD-10 codes from electronic medical records.
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Baseline through study completion, average 10 years
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All-Cause Mortality
Periodo de tiempo: Baseline through study completion, average 10 years
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All-cause mortality, defined as death from any cause, identified through linkage with death registration databases.
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Baseline through study completion, average 10 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Life Expectancy
Periodo de tiempo: Baseline through study completion, average 10 years
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Estimated remaining life expectancy stratified by biological aging status (PhenoAgeAccel) using parametric survival models.
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Baseline through study completion, average 10 years
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Disease-Free Healthspan
Periodo de tiempo: Baseline through study completion, average 10 years
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Estimated years of life free from major chronic diseases, calculated as the difference between life expectancy and time spent with chronic diseases
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Baseline through study completion, average 10 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIT-O-2024-136
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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