- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Xi-jian Dai, Doctor
- Numero di telefono: 13755756959
- Email: daixjdoctor@126.com
Luoghi di studio
-
-
Jiangxi
-
Nanchang, Jiangxi, Cina, 330006
- Reclutamento
- Second Affiliated Hospital of Nanchang University
-
Contatto:
- Xi-Jian Dai Xi-Jian Dai, MD
- Numero di telefono: +86-137-5575-6959
- Email: daixjdoctor@126.com
-
Contatto:
- Email: daixjdoctor@126.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Major Chronic Diseases
Lasso di tempo: 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.
|
Baseline through study completion, average 10 years
|
|
All-Cause Mortality
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Life Expectancy
Lasso di tempo: Baseline through study completion, average 10 years
|
Estimated remaining life expectancy stratified by biological aging status (PhenoAgeAccel) using parametric survival models.
|
Baseline through study completion, average 10 years
|
|
Disease-Free Healthspan
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIT-O-2024-136
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Phenotypic Age Acceleration
-
Women and Infants Hospital of Rhode IslandNon ancora reclutamentoDiabete gestazionale | Piccolo per età gestazionale | Ipoglicemia neonatale | Obesità materna che complica la gravidanza | Age grande per gestazionale
Prove cliniche su No Intervention (Observational Study)
-
IRCCS San RaffaeleAttivo, non reclutanteCarcinoma polmonare non a piccole cellule | Carenza di ricombinazione omologa | Inibitore PARP | EGFRItalia
-
Cairo UniversityNon ancora reclutamentoQualità del sonno, idoneità fisica e indice di massa corporea
-
PeriPharmNon ancora reclutamentoEczema | Dermatite atopica | Caregiver | Fardello | Eczema Dermatite Atopica
-
PeriPharmCompletatoLupus | Artrite da lupus | Lupus Artrite, Lupus Eritematoso Sistemico | Qualità della vita (QOL)Canada
-
Cancer Institute and Hospital, Chinese Academy...Non ancora reclutamentoIntelligenza artificiale | Sintomi e Segni | Valutazione dei bisogni | Applicazione mobile di intelligenza artificiale
-
PeriPharmNon ancora reclutamentoIdradenite Suppurativa (HS)
-
Cairo UniversityCompletatoSclerosi multipla recidivante-remittenteEgitto