Penn Biobank Return of Research Results Program

Cancer Clinical Trial

Official title:

A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242667
• Other study ID #: 833373
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 1, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing

2. English speaking

3. Aged 18 years or older

4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results

5. Have an actionable mutation or have been selected as a control participant

6. Have not previously received actionable results of clinical genetic testing

Exclusion Criteria:

1. Deceased assessed by electronic medical record, death index or identified after contact

2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

Related Conditions & MeSH terms

• Amyloidosis
• Cancer
• Cardiovascular Diseases
• Hereditary Cancer
• Hereditary Cardiac Amyloidosis

Intervention

Behavioral:
• e-Health (web-based) disclosure portal
Patient uses secure web-based portal to access genetic research results
• Provider mediated disclosure
Patient has disclosure of genetic research result by a provider (genetic counselor)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of surveys	Participant will self-complete surveys to collect psychological and knowledge outcomes	Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months