Penn Biobank Return of Research Results Program

NCT ID: NCT04242667

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Cardiovascular Diseases Hereditary Cancer Hereditary Cardiac Amyloidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Actionable gene result for cancer risk

Group Type EXPERIMENTAL

e-Health (web-based) disclosure portal

Intervention Type BEHAVIORAL

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

Provider mediated disclosure

Intervention Type BEHAVIORAL

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

Actionable gene result for cardiovascular disease risk

Group Type EXPERIMENTAL

e-Health (web-based) disclosure portal

Intervention Type BEHAVIORAL

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

Provider mediated disclosure

Intervention Type BEHAVIORAL

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

Interventions

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e-Health (web-based) disclosure portal

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

Intervention Type BEHAVIORAL

Provider mediated disclosure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fox Chase Cancer Center

OTHER

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Bradbury, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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833373

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 08021

Identifier Type: -

Identifier Source: org_study_id

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