NCT06347393

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 29, 2024

Last Update Submit

March 11, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Breast Cancer

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

    1 year

Secondary Outcomes (1)

  • The adherence rate to the screening

    1 year

Study Arms (1)

Observational Prospective Cohort

OTHER

Mammography and breast ultrasound

Diagnostic Test: Mammography and Breast Ultrasound

Interventions

Mammography and Breast UltrasoundDIAGNOSTIC_TEST

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

Observational Prospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent

You may not qualify if:

  • Refuse to sign Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MammographyUltrasonography, Mammary

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyDiagnostic Techniques, Obstetrical and Gynecological

Study Officials

  • Anna D'Angelo

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 4, 2024

Study Start

May 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)