Penn Biobank Return of Research Results Program

June 28, 2024 updated by: Abramson Cancer Center at Penn Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Actionable gene result for cancer risk
Behavioral: e-Health (web-based) disclosure portal
Patient uses secure web-based portal to access genetic research results
Behavioral: Provider mediated disclosure
Patient has disclosure of genetic research result by a provider (genetic counselor)
Experimental: Actionable gene result for cardiovascular disease risk
Behavioral: e-Health (web-based) disclosure portal
Patient uses secure web-based portal to access genetic research results
Behavioral: Provider mediated disclosure
Patient has disclosure of genetic research result by a provider (genetic counselor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of surveys
Time Frame: Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Fox Chase Cancer Center

Investigators

  • Principal Investigator: Angela Bradbury, M.D., University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 08021
  • 833373 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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