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Trial Title:
Transgender and Gender Diverse Individuals Screening for Breast Cancer
NCT ID:
NCT06347393
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Mammography and Breast Ultrasound
Description:
Patients will be scanned using mammography and Breast Ultrasound for Breast Cancer
Screening
Arm group label:
Observational Prospective Cohort
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
Istituto Europeo di Oncologia
Agency class:
Other
Collaborator:
Agency:
Luigi Sacco University Hospital
Agency class:
Other
Collaborator:
Agency:
Fatebenefratelli Hospital
Agency class:
Other
Collaborator:
Agency:
Ospedale Policlinico San Martino
Agency class:
Other
Collaborator:
Agency:
Università degli studi di Messina, Messina
Agency class:
Other
Collaborator:
Agency:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class:
Other
Collaborator:
Agency:
Arcispedale Santa Maria Nuova-IRCCS
Agency class:
Other
Collaborator:
Agency:
Federico II University
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero-Universitaria Careggi
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06347393
