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Population-level screening for Genetic Predisposition

N/A
Waitlist Available
Led By Elizabeth M Swisher, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial will help assess whether offering genetic testing to those at high risk for hereditary cancer and creating a "previvor" plan helps patients and their providers manage their care.

Eligible Conditions
  • Genetic Predisposition

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of testing
Rates of screening
Secondary outcome measures
Communication with family members
Cost-benefit analysis - budget impact
Cost-benefit analysis - cost-effectiveness
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Point of CareExperimental Treatment1 Intervention
In the point of care (POC) arm, patients will be approached at the time they come in to the clinic for a routine visit with their primary care provider. We will screen patients for familial cancer risk using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
Group II: Direct Patient EngagementExperimental Treatment1 Intervention
In the direct patient engagement (DPE) arm, patients will be identified by reviewing clinic records to create an "active" patient list (i.e., those who have had a visit in the past year). We will contact patients by postal mail and email to provide a link to the online risk screening tool. The patient outreach is not tied to a specific visit and the online screening can be completed at any time. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
Group III: Stakeholder Interviews and SurveysActive Control1 Intervention
Samples of patients, providers, and clinic leaders will be assessed at several points throughout the study - baseline and multiple follow-ups. We will use a mixed methods approach, with both quantitative assessments (surveys) and qualitative assessments (interviews). Baseline assessments will provide initial data on the patient population and current clinic functioning and help in implementation planning. The midpoint and final assessments will provide estimates of change in patients, providers, and clinic leaders as a result of the implementation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Population-level screening
2020
N/A
~20190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,933,130 Total Patients Enrolled
University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,818,460 Total Patients Enrolled
Elizabeth M Swisher, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
31 Total Patients Enrolled
~4325 spots leftby Jun 2025
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