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Active, Not Recruiting

NCT Number: NCT06347393

Transgender and Gender Diverse Individuals Screening for Breast Cancer

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mammography and Breast Ultrasound

Diagnostic Test

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

Primary outcomes

  1. Incidence of Breast Cancer

    Time frame: 1 year

    The incidence of BC in a selected population of transgender and gender-diverse individuals.

Secondary outcomes

  1. The adherence rate to the screening

    Time frame: 1 year

    To 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda USL Reggio Emilia - IRCCS
  • Fatebenefratelli Hospital
  • Federico II University
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Istituto Europeo di Oncologia
  • Luigi Sacco University Hospital
  • Ospedale Policlinico San Martino
  • Università degli studi di Messina, Messina

Registry information

Official study title

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

Acronym: GENESIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 4, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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