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Direct Contact Genetic Screening for High Cholesterol

N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Proband must be a KCNQ1 Thr224Met or APOB R3527Q carrier
Proband must be 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion: approximately 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test two methods of screening at-risk family members for genetic variants that may increase their risk of disease.

Who is the study for?
This trial is for adults who carry the KCNQ1 Met224Thr or APOB Arg3527Gln genetic variant, which can be linked to conditions like Long QT Syndrome and high cholesterol. Their first-degree relatives are also eligible as part of a family-based screening approach.
What is being tested?
The study compares two methods of informing family members about their risk for certain genetic conditions: direct contact by the study team versus indirect contact initiated by the patient (proband). It aims to determine which method is more effective and respectful of privacy.
What are the potential side effects?
There are no direct physical side effects from participating in this trial since it involves communication strategies rather than medical treatments. However, there may be mental or psychosocial impacts due to learning about one's genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I carry the KCNQ1 Thr224Met or APOB R3527Q gene mutation.
Select...
I am 18 years old or older.
Select...
A close family member has the KCNQ1 Thr224Met or APOB Arg3527Gln mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion: approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Uptake of cascade screening among all first-degree relatives
Secondary study objectives
Anxiety regarding method of contact questionnaire
Knowledge of disease and variant questionnaire
Number of new cases detected among all first-degree family members
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Direct contactExperimental Treatment1 Intervention
Study team contact of family members
Group II: Indirect contactActive Control1 Intervention
Proband initiated contact of family members

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,435 Total Patients Enrolled

Media Library

Direct contact of family members for cascade screening of relevant variants Clinical Trial Eligibility Overview. Trial Name: NCT05348564 — N/A
Genetic Testing Research Study Groups: Direct contact, Indirect contact
Genetic Testing Clinical Trial 2023: Direct contact of family members for cascade screening of relevant variants Highlights & Side Effects. Trial Name: NCT05348564 — N/A
Direct contact of family members for cascade screening of relevant variants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348564 — N/A
~91 spots leftby Mar 2026
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