Status:
ACTIVE_NOT_RECRUITING
Immediate Breast Reconstruction Following Mastectomy (IRMA)
Lead Sponsor:
Thurgau Breast Center
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Brief Summary
Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), the rates of nipple-sparing mastectomy (NSM) have risen 202% since 2009. In spite of the increasing popularity of IR...
Detailed Description
This is a multicenter observational, cohort study. The study is designed to serve a similar purpose as a disease registry. The only study-specific intervention will be the completion of the BREAST-Q q...
Eligibility Criteria
Inclusion
- Any women ≥ 18 years of age undergoing IRMA (NSM or SSM) at any participating breast center may be included in the study.
- Women undergoing IRMA for either prophylactic or oncologic purposes
- Enrolment is possible up to 90 days after mastectomy
- A patient who has had the mastectomy at a non-participating institution, but has subsequently sought treatment at one of the study centers, may be eligible for enrolment up to 90 days following mastectomy
Exclusion
- Unwillingness to have follow-up assessments at the participating breast centers
- Limited ability to understand study-specific procedures, which includes language difficulties.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2030
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT04390529
Start Date
January 1 2018
End Date
April 30 2030
Last Update
May 15 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Kantonsspital Aarau AG
Aarau, Canton of Aargau, Switzerland, 5001
2
Kantonsspital Baden, Prof. Dr. med. Cornelia Leo
Baden, Canton of Aargau, Switzerland, 5404
3
Brustzentrum Bern Biel, Hirslanden
Bern, Canton of Bern, Switzerland, 3013
4
Centre du Sein de Genève - Hirslanden Clinique des Grangettes
Chêne-Bougeries, Canton of Geneva, Switzerland, 1224