Clincosm LogoSign in Get a demo

Penn Biobank Return of Research Results Program

Sponsor
University of Pennsylvania (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04242667
Collaborator
Fox Chase Cancer Center (Other)
100
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: e-Health (web-based) disclosure portal
  • Behavioral: Provider mediated disclosure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Completion of surveys [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Fox Chase Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04242667
Other Study ID Numbers:
  • 833373
First Posted:
Jan 27, 2020
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases
Amyloidosis

Study Results

No Results Posted as of Aug 18, 2021