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Implementing Polygenic Risk Scores for Breast Cancer Prevention: a Feasibility Study

Study acronym: MIG
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 3, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 6 months later Mar 31, 2026 → Sep 30, 2026
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Catholic University of the Sacred Heart

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 31, 2026 to Sep 30, 2026v5 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Boccia Stefania to Catholic University of the Sacred Heart
    • Recruitment opened
    • Study completion pushed from May 30, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 40 words
  2. Lead sponsor: Boccia Stefania to Catholic University of the Sacred Heartv4 Show 11 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 31, 2026 to Sep 30, 2026
    • Primary endpoints: 2 to 1
    • Study sites: 0 to 1
    • Study completion date: May 30, 2026 to Nov 30, 2026
    • Start date changed from estimate of Jun 9, 2025 to Jun 6, 2025
    • Interventions: Integrated PRS-Enhanced Breast Cancer Risk Assessment (CanRisk model) (Diagnostic Test) to Clinical pathway for breast cancer prevention based on PRS-integrated CanRisk assessment (Genetic)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 4 to 6
    • Study description shortened, about 215 words
    • Collaborators shortened, about 6 words
  3. Start date: Apr 15, 2025 to Jun 9, 2025
    • Study completion date: Apr 30, 2026 to May 30, 2026
    • Secondary endpoints: details revised at 1 of 4 entries
    v3
  4. Enrollment target: 510 to 100
    • Study description shortened, about 319 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This single-arm interventional feasibility study will evaluate whether integrating polygenic risk scores (PRS) into the CanRisk model can improve breast cancer risk prediction and personalized prevention in women at risk of breast cancer. The study will assess the organizational feasibility, patient acceptance, emotional impact and satisfaction of an integrated pathway combining PRS testing with standard genetic counseling and other risk factors at Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial Details
NCT Number NCT06922708
Lead Sponsor Catholic University of the Sacred Heart
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Genetic Risk Score
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov