跳至主要内容
临床试验/NCT06347393
NCT06347393进行中(未招募)不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,600
试验地点
2
主要终点
Incidence of Breast Cancer

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Refuse to sign Informed Consent

结局指标

主要结局

Incidence of Breast Cancer

时间窗: 1 year

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

次要结局

  • The adherence rate to the screening(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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