Breast CancerGENESISNCT06347393
Transgender and Gender Diverse Individuals Screening for Breast Cancer
A study testing Mammography and Breast Ultrasound in people with Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography and Breast Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transgender and gender-diverse individuals ≥18 years old who meet the ACR inclusion criteria
- Signed Informed Consent
Who cannot join
- Refuse to sign Informed Consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
About this study
Official title: Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study
The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Mammography and Breast Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography and Breast UltrasoundDiagnostic test
Patients will be scanned using mammography and Breast Ultrasound for Breast Cancer Screening
| Study group | Role | What they receive |
|---|---|---|
| Observational Prospective Cohort | Other | Mammography and breast ultrasound Receives: Diagnostic Test: Mammography and Breast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Breast Cancer
The incidence of BC in a selected population of transgender and gender-diverse individuals.
Measured: 1 year
Secondary outcomes (1)
The adherence rate to the screening
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 May 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Europeo di Oncologia, Luigi Sacco University Hospital, Fatebenefratelli Hospital, Ospedale Policlinico San Martino, Università degli studi di Messina, Messina, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Azienda USL Reggio Emilia - IRCCS, Federico II University, Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Sponsor
- Investigators
- Anna D'Angelo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347393
- Sponsor's protocol ID
- 6425
- Acronym
- GENESIS
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study
- ClinicalTrials.gov ID
- NCT06347393
- Acronym / sponsor ID
- GENESIS / 6425
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Istituto Europeo di Oncologia, Luigi Sacco University Hospital, Fatebenefratelli Hospital, Ospedale Policlinico San Martino, Università degli studi di Messina, Messina, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Azienda USL Reggio Emilia - IRCCS, Federico II University, Azienda Ospedaliero-Universitaria Careggi
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Prospective Cohort | Other | Diagnostic Test: Mammography and Breast UltrasoundMammography and breast ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Transgender and gender-diverse individuals ≥18 years old who meet the ACR inclusion criteria
- Signed Informed Consent
Key exclusion criteria (1 listed)
- Refuse to sign Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mammography and Breast UltrasoundPatients will be scanned using mammography and Breast Ultrasound for Breast Cancer Screening | Diagnostic test | Observational Prospective Cohort |
Primary outcome
Incidence of Breast Cancer
Time frame: 1 year
The incidence of BC in a selected population of transgender and gender-diverse individuals.
1 secondary outcome
The adherence rate to the screening
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna D'Angelo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography and Breast Ultrasound in people with Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Breast Cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.