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Penn Medicine Biobank Return of Results Program

Study acronym: ROR
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 1, 2026 → Oct 22, 2026
See other at-risk trials from Abramson Cancer Center at Penn Medicine

Record History

  1. Primary completion pushed from Jul 1, 2026 to Oct 22, 2026 Completion pushed from Sep 30, 2026 to Mar 31, 2027 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 4 of 6 entries Show 3 more changesShow less
    • Completion pushed from Sep 30, 2026 to Mar 31, 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 4 of 6 entries
  2. Trial status changed: Enrolling by Invitation → Active, Not Recruiting Primary completion pushed from Apr 1, 2026 to Jul 1, 2026 · Completion pushed from Aug 31, 2026 to Sep 30, 2026v6 Show 2 more changesShow less
    • Primary completion pushed from Apr 1, 2026 to Jul 1, 2026
    • Completion pushed from Aug 31, 2026 to Sep 30, 2026
  3. Primary completion date: Jan 1, 2026 to Apr 1, 2026 Completion date: Mar 31, 2026 to Aug 31, 2026v5 Show 1 more changeShow less
    • Completion date: Mar 31, 2026 to Aug 31, 2026
  4. Primary completion date: Mar 31, 2025 to Jan 1, 2026 Completion date: Jul 1, 2025 to Mar 31, 2026v4 Show 1 more changeShow less
    • Completion date: Jul 1, 2025 to Mar 31, 2026
  5. Lead sponsor: University of Pennsylvania to Abramson Cancer Center at Penn Medicine Primary completion date: Aug 1, 2024 to Mar 31, 2025 · Completion date: Apr 1, 2025 to Jul 1, 2025v3 Show 2 more changesShow less
    • Primary completion date: Aug 1, 2024 to Mar 31, 2025
    • Completion date: Apr 1, 2025 to Jul 1, 2025
  6. Secondary endpoints: details revised at 1 of 6 entriesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this hybrid type 1 effectiveness-implementation study is to evaluate and compare different ways of delivering genetic research results to participants. The main questions the study aims to answer are: * Is sharing actionable genetic research results with participants through a multimedia patient-informed eHealth intervention (e.g. patient portal) no worse than sharing results by telephone or videoconference with a genetic counselor? * Will research participants access an eHealth educational intervention or chatbot education to learn about research results being offered and the option to decline learning their individual research results and how frequently participants choose to decline actionable research results? * Who benefits less and more from digital intervention with return of actionable research results and what barriers exist to using these tools for return of research results outside this study? Participants in the biobank will be offered digital tools to learn about research results being offered and the option to decline receiving these results. Those who don't decline and have an actionable result will be randomly assigned to receive their results with a genetic counselor or through an eHealth portal. Participants will complete surveys before and after receipt of results to understand patient experiences with these methods of education and return of results to determine if digital tools can be used to help ensure more patients get access to research results which could impact their health.
Trial Details
NCT Number NCT06089954
Lead Sponsor Abramson Cancer Center at Penn Medicine
Collaborators: Fox Chase Cancer Center, Columbia University, Thomas Jefferson University
Conditions Genetic Disease, Cancer, Cardiovascular Diseases
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov