Early disclosure of genetic testing results for Genetic Testing

University of Utah John A. Moran Eye Center, Salt Lake City, UT
Genetic Testing+2 More ConditionsEarly disclosure of genetic testing results - Behavioral
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether or not receiving AMD genetic testing leads people to make healthier lifestyle choices as measured by their carotenoid status.

Eligible Conditions
  • Nutritional Biomarkers
  • Genetic Testing
  • Age-Related Macular Degeneration

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline and Month 12

Baseline and Month 12
Chang in serum carotenoid status in response to genetic risk disclosure
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume
Change in skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy
Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Late Genetic Results Disclosure
1 of 2
Early Genetic Results Disclosure
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Early disclosure of genetic testing results · No Placebo Group · Phase 2

Early Genetic Results Disclosure
Behavioral
Experimental Group · 1 Intervention: Early disclosure of genetic testing results · Intervention Types: Behavioral
Late Genetic Results Disclosure
Behavioral
ActiveComparator Group · 1 Intervention: Late disclosure of genetic testing results · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and month 12

Who is running the clinical trial?

Paul S. BernsteinLead Sponsor
2 Previous Clinical Trials
56 Total Patients Enrolled
Paul Bernstein, MD, PhDPrincipal InvestigatorUniversity of Utah Moran Eye Center
2 Previous Clinical Trials
10,065 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Only people of Caucasian descent can participate because the genetic test used in this study is only proven to work in that population.
Having a family history of AMD is not required, but it is okay if you do have one.

Frequently Asked Questions

Has the FDA approved dispensing genetic test results prior to completion?

"With limited data on efficacy, but some evidence of safety, the Early disclosure of genetic testing results has been assigned a score of 2." - Anonymous Online Contributor

Unverified Answer

Are octogenarians being included in the enrollment process of this medical experiment?

"This research project is open to participants aged 18 and over, but below 64 years old." - Anonymous Online Contributor

Unverified Answer

What is the enrollment quota for this research study?

"Affirmative. According to the data on clinicaltrials.gov, this study is actively searching for participants and has been since August 3rd 2022. The most recent edit was made 8 days later, on August 10th 2022, with a requirement of 80 recruits from one location." - Anonymous Online Contributor

Unverified Answer

Who meets the eligibility criteria for participating in this clinical experiment?

"This research requires 80 participants of Caucasian heritage between 18 and 64 years old that have had genetic testing. It is not a requirement to show familial history of AMD, yet this could be beneficial for the study." - Anonymous Online Contributor

Unverified Answer

Is enrollment currently available for this research project?

"Affirmative. According to information found on clinicaltrials.gov, this experiment is actively recruiting participants who meet its criteria and was last updated August 10th 2022. A total of 80 patients are required from 1 medical centre for the trial's completion." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.