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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
13,657 Previous Clinical Trials
40,913,483 Total Patients Enrolled
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,824,167 Total Patients Enrolled
Elizabeth M Swisher, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are currently enrolled in this experiment?

"Affirmative. Clinicaltrials.gov's records show that this medical trial, posted on September 25th 2020, is in the midst of recruiting participants. This particular research requires 24000 people to enrol from two separate locations."

Answered by AI

Are there any remaining slots for prospective participants in this trial?

"Indeed, clinicaltrials.gov reveals that this study is actively enrolling participants. It was initially posted on September 25th 2020 and the most recent update occurred February 17th 2022. There are over 24000 patients needed for recruitment from two different medical centres."

Answered by AI

What outcomes is the research team hoping to observe in this trial?

"This medical trial, which will be assessed over the course of 18 months, is intended to measure test completion rates. Secondary outcomes include a Trust in Physician Scale (TIPS), communication with family members via a self-developed metric and reasons for completing (or not) genetic testing as per another customised measurement."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
MultiCare Health System
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. MultiCare Health System: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Early Detection of GEnetic Risk (EDGE)
Elizabeth Swisher 2020. "Early Detection of GEnetic Risk (EDGE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04746794.
~4485 spots leftby Apr 2025
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