Child-Parent Familial Hypercholesterolemia Screening
Child-Parent Screening of Familial Hypercholesterolemia in Children
1 other identifier
observational
15,000
1 country
6
Brief Summary
Child-parent screening for familial hypercholesterolemia has been proposed to identify children and their parent who are carrier of mutations and with high risk for inherited premature coronary artery disease. The investigators assessed the efficacy and feasibility of such screening in primary care practice. key scientific questions:
- 1.The 95th and 99th percentile of finger blood TC in children of 2 years old.
- 2.Mutations that contribute to high TC status ( serum TC \>99th percentiles) compared with international FH48 panel for FH genetic screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 15, 2026
May 1, 2026
1.5 years
August 25, 2020
May 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The affected status of Familial Hypercholesterolemia
heterozygote or homozygote carriers of established FH mutations in LDLR, PSCK9 and APOB gene, including mutations included in the FH48 and new ones identified in Chinese children
At enrollment
Secondary Outcomes (3)
fasting total cholesterol level by Fingertip capillary blood test in children around 2 years old
At enrollment
affected status of known FH mutation
At enrollment
fasting serum LDL-c levels of children with finger TC over P95
At enrollment
Interventions
it is a observational study, do not have interventions.
Eligibility Criteria
All community-children from slelected communities aged 1 to 3 who receive regular child care (programmed immunization vaccination clinic) within a prespecified study period
You may qualify if:
- Receive routine child care
- aged 1 - 3 years old ( date of investigate minus date of birth)
You may not qualify if:
- It is up to the researcher to decide whether it is suitable to participate in this research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Qidong Women and Children Hospital
Qidong, Jiangsu, China
Weili Yan
Shanghai, Shanghai Municipality, 201102, China
Shanxi Provincial Children's Hospital
Taiyuan, Shanxi, China
Chongqin Medical University Affiliated Children's Hospital
Chongqing, Sichuan, China
Urumqi Children's Hospital
Ürümqi, Xinjiang, 830000, China
Biospecimen
capillary blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
LIling Qian, Master
Children's Hospital of Fudan University
- STUDY DIRECTOR
Rui Dong, MD
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 28, 2020
Study Start
April 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 15, 2026
Record last verified: 2026-05