Clinical trial NCT04390529: Immediate Breast Reconstruction Following Mastectomy (IRMA)
Official title: A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Female
Lead sponsor: Thurgau Breast Center
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 515
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IRMA (NSM: nipple-areola sparing mastectomy or SSM: skin-sparing mastectomy) at any participating breast center may be included in the study. Patients undergoing IRMA for either prophylactic or oncologic purposes are eligible.

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.

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.

Primary outcomes:
measure: Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery
timeFrame: Three years after surgery
measure: Rate of infection requiring surgery
timeFrame: Three years after surgery
measure: Grade of surgical complications
timeFrame: Three years after surgery
Secondary outcomes:
measure: Rate of minor complications not requiring surgery
timeFrame: Three years after surgery
measure: Level of patient satisfaction with cosmesis
timeFrame: Five years after surgery
measure: Level of sensitivity of the operated breast (NAC) compared to the non-operated breast
timeFrame: Five years after surgery
measure: Rate of breast cancer recurrence
timeFrame: Five years after surgery
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
state: Aargau
city: Baden
country: Switzerland
facility: Kantonsspital Baden, Prof. Dr. med. Cornelia Leo
state: Aargau
city: Bern
country: Switzerland
facility: Brustzentrum Bern Biel, Hirslanden
state: BE
city: Chêne-Bougeries
country: Switzerland
facility: Centre du Sein de Genève - Hirslanden Clinique des Grangettes
state: GE
city: St. Gallen
country: Switzerland
facility: Tumor- und Brustzentrum ZeTuP
state: Saint Gallen
city: St. Gallen
country: Switzerland
facility: Tumor- und BrustZentrum Ostschweiz
state: Saint Gallen
city: St. Gallen
country: Switzerland
facility: Brustzentrum Ostschweiz
state: SG
city: Frauenfeld
country: Switzerland
facility: Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr
state: Thurgau
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano)
state: Ticino
city: Wetzikon
country: Switzerland
facility: Spital Wetzikon
state: ZH
city: Zollikerberg
country: Switzerland
facility: Brust Centrum Zürich, Bethanien & Zollikerberg
state: ZH
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
state: ZH
city: Bern
country: Switzerland
facility: Campus SLB Sonnenhof AG
city: Genève
country: Switzerland
facility: HUG - Hôpitaux universitaires de Genève
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Klinik für Gynäkologie
Study officials:
affiliation: Brustzentrum Thurgau, Spital Thurgau AG
name: Mathias Fehr, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: