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OpenTrials
Completed

NCT Number: NCT04242667

Penn Biobank Return of Research Results Program

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.

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Key information

Conditions

Cancer Cardiovascular Diseases Hereditary Cancer Hereditary Cardiac Amyloidosis Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
  • English speaking
  • Aged 18 years or older
  • Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
  • Have an actionable mutation or have been selected as a control participant
  • Have not previously received actionable results of clinical genetic testing

Exclusion criteria

  • Deceased assessed by electronic medical record, death index or identified after contact
  • Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

Treatment and study plan

e-Health (web-based) disclosure portal

Behavioral

Patient uses secure web-based portal to access genetic research results

Provider mediated disclosure

Behavioral

Patient has disclosure of genetic research result by a provider (genetic counselor)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Fox Chase Cancer Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2020
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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