- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Xi-jian Dai, Doctor
- Número de telefone: 13755756959
- E-mail: daixjdoctor@126.com
Locais de estudo
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- Recrutamento
- Second Affiliated Hospital of Nanchang University
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Contato:
- Xi-Jian Dai Xi-Jian Dai, MD
- Número de telefone: +86-137-5575-6959
- E-mail: daixjdoctor@126.com
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Contato:
- E-mail: daixjdoctor@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
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|
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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Major Chronic Diseases
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Life Expectancy
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIT-O-2024-136
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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