Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT06347393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transgender and Gender Diverse Individuals Screening for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}, {'id': 'D016217', 'term': 'Ultrasonography, Mammary'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Breast Cancer', 'timeFrame': '1 year', 'description': 'The incidence of BC in a selected population of transgender and gender-diverse individuals.'}], 'secondaryOutcomes': [{'measure': 'The adherence rate to the screening', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transgender and gender-diverse individuals ≥18 years old who meet the ACR inclusion criteria\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Refuse to sign Informed Consent'}, 'identificationModule': {'nctId': 'NCT06347393', 'acronym': 'GENESIS', 'briefTitle': 'Transgender and Gender Diverse Individuals Screening for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Transgender and GENdEr diverSe Individuals Screening for Breast Cancer: the GENESIS Study', 'orgStudyIdInfo': {'id': '6425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Observational Prospective Cohort', 'description': 'Mammography and breast ultrasound', 'interventionNames': ['Diagnostic Test: Mammography and Breast Ultrasound']}], 'interventions': [{'name': 'Mammography and Breast Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be scanned using mammography and Breast Ultrasound for Breast Cancer Screening', 'armGroupLabels': ['Observational Prospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': "Anna D'Angelo", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Europeo di Oncologia', 'class': 'OTHER'}, {'name': 'Luigi Sacco University Hospital', 'class': 'OTHER'}, {'name': 'Fatebenefratelli Hospital', 'class': 'OTHER'}, {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, {'name': 'Università degli studi di Messina, Messina', 'class': 'UNKNOWN'}, {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, {'name': 'Federico II University', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}