Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT06347393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transgender and Gender Diverse Individuals Screening for Breast Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENESIS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: