- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xi-jian Dai, Doctor
- Numéro de téléphone: 13755756959
- E-mail: daixjdoctor@126.com
Lieux d'étude
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Jiangxi
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Nanchang, Jiangxi, Chine, 330006
- Recrutement
- Second Affiliated Hospital of Nanchang University
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Contact:
- Xi-Jian Dai Xi-Jian Dai, MD
- Numéro de téléphone: +86-137-5575-6959
- E-mail: daixjdoctor@126.com
-
Contact:
- E-mail: daixjdoctor@126.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Major Chronic Diseases
Délai: Baseline through study completion, average 10 years
|
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
Délai: Baseline through study completion, average 10 years
|
All-cause mortality, defined as death from any cause, identified through linkage with death registration databases.
|
Baseline through study completion, average 10 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Life Expectancy
Délai: Baseline through study completion, average 10 years
|
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
|
|
Disease-Free Healthspan
Délai: Baseline through study completion, average 10 years
|
Estimated years of life free from major chronic diseases, calculated as the difference between life expectancy and time spent with chronic diseases
|
Baseline through study completion, average 10 years
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIT-O-2024-136
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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