Skip to content

Transgender and Gender Diverse Individuals Screening for Breast Cancer

Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06347393
Acronym
GENESIS
Enrollment
1600
Registered
2024-04-04
Start date
2024-05-01
Completion date
2026-03-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DIAGNOSTIC_TESTMammography and Breast Ultrasound

Patients will be scanned using mammography and Breast Ultrasound for Breast Cancer Screening

Sponsors

Istituto Europeo di Oncologia
CollaboratorOTHER
Luigi Sacco University Hospital
CollaboratorOTHER
Fatebenefratelli Hospital
CollaboratorOTHER
Ospedale Policlinico San Martino
CollaboratorOTHER
Università degli studi di Messina, Messina
CollaboratorUNKNOWN
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
Azienda USL Reggio Emilia - IRCCS
CollaboratorOTHER_GOV
Federico II University
CollaboratorOTHER
Azienda Ospedaliero-Universitaria Careggi
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Breast Cancer1 yearThe incidence of BC in a selected population of transgender and gender-diverse individuals.

Secondary

MeasureTime frameDescription
The adherence rate to the screening1 yearTo evaluate the adherence rate to the screening, to estimate the relative risk of BC according to the subgroup of population considered and to identify risk factors.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026