Clinical trial NCT06347393: Transgender and Gender Diverse Individuals Screening for Breast Cancer
Official title: Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Istituto Europeo di Oncologia
name: Luigi Sacco University Hospital
name: Fatebenefratelli Hospital
name: Ospedale Policlinico San Martino
name: Università degli studi di Messina, Messina
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Azienda USL Reggio Emilia - IRCCS
name: Federico II University
name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2024-04-04
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population.

Detailed description: In recent years, the scientific community has been paying increasing attention to lesbian, gay, bisexual, transgender, queer, intersexual, asexual population, with a special focus on transgender and gender-diverse individuals. Globally, the percentage of adults who identify themselves as transgender varies between 0.3% and 0.5%, while approximately 0.5% to 4.5% of adults are estimated to identify as gender-diverse. Despite the growing visibility of transgender and gender-diverse community and the efforts towards their depathologization, healthcare still needs to address two fundamental issues: the inadequate preparation of healthcare staff regarding gender incongruence which results in mistreatment and discrimination and the lack of uniform and large-scale prospective data. Scientific evidence regarding the risk of developing breast cancer (BC) in these patients and the related benefits of BC screening are still limited and insufficient. The Associazione Italiana di Oncologia Medica (AIOM), reported that the risk of developing BC tends to increase in transgender women compared to cisgender men (standardized incidence ratio \[SIR\], 46.7; 95% CI, 27.2-75.4), although it does not reach the level of risk in cisgender women (SIR, 0.3; 95% CI, 0.2-0.4). Conversely, in transgender men, the risk of BC decreases when compared to cisgender women (SIR, 0.2; 95% CI, 0.1-0.5), but it still remains higher than the risk present in cisgender men (58.9; 95% CI, 18.7-142.2).As for the screening programs, there is a lower adherence among the transgender and non-conforming-gender population compared to the cisgender population, due to socio-economic barriers and a lack of clear recommendations supported by scientific evidence.The National Comprehensive Cancer Network (NCCN)and AIOM guidelines currently do not include specific recommendations for transgender individuals due to the aforementioned lack of scientific evidence.

The American College of Radiology (ACR) regulates screening protocols for the transgender population based on factors such as age, hormone therapy exposure, surgical history, and risk categories.

Eligibility criteria: Inclusion Criteria:

* Transgender and gender-diverse individuals ≥18 years old who meet the ACR inclusion criteria
* Signed Informed Consent

Exclusion Criteria:

* Refuse to sign Informed Consent

Primary outcomes:
measure: Incidence of Breast Cancer
timeFrame: 1 year
Secondary outcomes:
measure: The adherence rate to the screening
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Anna D'Angelo
role: PRINCIPAL_INVESTIGATOR
References: