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International Prospective REgistry on Pre-pectorAl Breast REconstruction

Study acronym: I-PREPARE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Sep 10, 2027 → Dec 15, 2028
See other at-risk trials from European Breast Cancer Research Association of Surgical Trialists

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 10, 2027 to Dec 15, 2028
    • Sponsor changed: IRCCS San Raffaele to European Breast Cancer Research Association of Surgical Trialists
    • Study completion pushed from Sep 10, 2027 to Jun 10, 2029
    v7
  2. Start date: Oct 16, 2023 to Sep 12, 2023v6
  3. Re-verified, no change to tracked fieldsv5
  4. Lead sponsor: Oreste Davide Gentilini to IRCCS San Raffaele
    • Start date: Dec 18, 2023 to Oct 16, 2023
    • Collaborator revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Start date changed from estimate of Jan 10, 2024 to Dec 18, 2023
    v3
  6. Start date: May 10, 2023 to Jan 10, 2024
    • Primary endpoint revised
    • Primary and study completion dates: May 10, 2027 to Sep 10, 2027
    • Secondary endpoints revised (5)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
Trial Details
NCT Number NCT05817175
Lead Sponsor European Breast Cancer Research Association of Surgical Trialists
Collaborators: EUBREAST ETS
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 1,236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov