- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Xi-jian Dai, Doctor
- 전화번호: 13755756959
- 이메일: daixjdoctor@126.com
연구 장소
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Jiangxi
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Nanchang, Jiangxi, 중국, 330006
- 모병
- Second Affiliated Hospital of Nanchang University
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연락하다:
- Xi-Jian Dai Xi-Jian Dai, MD
- 전화번호: +86-137-5575-6959
- 이메일: daixjdoctor@126.com
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연락하다:
- 이메일: daixjdoctor@126.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Major Chronic Diseases
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Life Expectancy
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Phenotypic Age Acceleration에 대한 임상 시험
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PeriPharm완전한
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IRCCS San Raffaele모집하지 않고 적극적으로