Status:
WITHDRAWN
Breast Reconstruction Following Breast Cancer in Very High Risk Patients
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Malignant Neoplasm of Breast
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparin...
Detailed Description
Primary Endpoint(s) 1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort 2. ...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
- Subjects must be breast reconstruction candidates using implant based breast reconstruction.
- Subjects must have a pre-operative risk \>20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Prior breast cancer surgical treatment
- Prior breast reconstruction
- Inability to provide written consent
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03261323
Start Date
May 31 2019
End Date
July 1 2022
Last Update
May 20 2022
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195