Pilot study of return of genetic results to individual participants of the large cohort study

Pilot study of return of genetic results to individual participants of the large cohort study - Pilot study of return of genetic results to individual participants of the large cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024288

Enrollment

135

Registered

2016-10-06

Start date

2016-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

familial hypercholesterolemia

Interventions

Participants of Tohoku Medical Megabank Cohort, with age over 20 years-old, and TC&gt

250 mg/dl, and/or LDL-C&gt

180 mg/dl, and/or a history of treatments of hyperlipidemia are returned the genetic results of familial hypercholesterolemia (LDLR, PCSK9, APOB), after the informed consent of this pilot study.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participants of Tohoku Medical Megabank Cohort 2) Age over 20 years-old 3) Participants whose genome was analyzed 4) TC>250 mg/dl, and/or LDL-C>180 mg/dl, and/or a history of treatments of hyperlipidemia

Exclusion criteria

Exclusion criteria: Participants who checked : No return of results

Design outcomes

Primary

Measure	Time frame
Primary outcome: Psychosocial impacts, distress and experiences of return of genetic results Measures: K6, POMS2, IES-R, Questionnaire for genetic literacy, Questionnaires and interviews for experiences of return of genetic results Timeline: Pre, post, after 6 months, 12 months	—

Secondary

Measure	Time frame
Secondary outcome: 1) Validation of genetic analysis 2) Attitudes, satisfactions, and effects of Genetic Lecture	—

Countries

Japan

Contacts

Public ContactHIROSHI KAWAME

Tohoku University Tohoku Medical Megabank Organization Group of return of genomic results

hkawame@megabank.tohoku.ac.jp022-274-5998

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026