Immediate Breast Reconstruction Following Mastectomy (IRMA)

NCT ID: NCT04390529

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 515 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2030-04-30

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 IRMA, limited research has been done to identify complications in patients undergoing these procedures. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure.

Active monitoring and periodic assessment of IRMA patients are needed to establish the safety of these different techniques in terms of complications and recurrence rates. Identifying an optimal strategy for IRMA may lead to the development of clinical guidelines, which are currently lacking.

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 quality-of-life (QoL) form. Only quantitative data will be collected. The rationale for this study design is to identify and describe the type and frequency of complications related to IRMA. No hypothesis is being tested. Although group comparisons based on surgical techniques will be made, conclusions based on these findings will be limited by the observational nature of the design.

Data from patients will be collected using a series of pseudonymized case report forms, including the validated quality-of-life questionnaire: BREAST-Q. These data will be entered into the web-based data collection system, SecuTrial. A precise description of the surgical procedure will be required, as specified on the case report forms (e.g., implantation of a mesh, resection margins), to allow for subsequent multivariate analyses.

During the first year of follow-up, data from routine clinical assessments and the QoL forms will be gathered at baseline (within 90 days after mastectomy), 6 and 12 months. Thereafter, data will be collected from annual clinical assessments and completion of the QoL form will be done for an additional four years (24, 36, 48 and 60 months postoperatively). Consequently, a total of five years of postoperative follow-up data will be collected to allow sufficient time for the development of the majority of foreseeable complications.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

quality-of-life questionnaire: BREAST-Q

quality-of-life questionnaire: BREAST-Q

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• Unwillingness to have follow-up assessments at the participating breast centers
• Limited ability to understand study-specific procedures, which includes language difficulties.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thurgau Breast Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Fehr, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Brustzentrum Thurgau, Spital Thurgau AG

Locations

Kantonsspital Aarau AG

Aarau, Canton of Aargau, Switzerland

Kantonsspital Baden, Prof. Dr. med. Cornelia Leo

Baden, Canton of Aargau, Switzerland

Brustzentrum Bern Biel, Hirslanden

Bern, Canton of Bern, Switzerland

Centre du Sein de Genève - Hirslanden Clinique des Grangettes

Chêne-Bougeries, Canton of Geneva, Switzerland

Tumor- und Brustzentrum ZeTuP

Sankt Gallen, Canton of St. Gallen, Switzerland

Brustzentrum Ostschweiz

Sankt Gallen, Canton of St. Gallen, Switzerland

Tumor- und BrustZentrum Ostschweiz

Sankt Gallen, Canton of St. Gallen, Switzerland

Spital Wetzikon

Wetzikon, Canton of Zurich, Switzerland

Brust Centrum Zürich, Bethanien & Zollikerberg

Zollikerberg, Canton of Zurich, Switzerland

Stadtspital Triemli

Zurich, Canton of Zurich, Switzerland

Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano)

Lugano, Canton Ticino, Switzerland

Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr

Frauenfeld, Thurgau, Switzerland

Campus SLB Sonnenhof AG

Bern, , Switzerland

HUG - Hôpitaux universitaires de Genève

Geneva, , Switzerland

Universitätsspital Zürich, Klinik für Gynäkologie

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

IRMA

Identifier Type: -

Identifier Source: org_study_id