Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06239766
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BC Risk Assessment Before Top Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-30', 'size': 1411723, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-16T10:39', 'hasProtocol': True}, {'date': '2023-02-20', 'size': 226397, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-16T10:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk.', 'timeFrame': '1 year', 'description': 'Validated breast cancer risk calculators (IBIS and Gail) will be used to determine lifetime breast cancer risk of participants enrolled into the study. Ranges and 95% CI will be made to estimate the percent of TGD persons at risk.'}, {'measure': 'Rate of uptake of oncologic risk reducing mastectomies as part of chest masculinization surgery in TGD persons at risk of breast cancer based on validated models.', 'timeFrame': '1 year', 'description': 'To determine whether those TGD persons at elevated risk of breast cancer development choose to undergo risk-reducing mastectomies as part of their chest masculinization surgery.'}, {'measure': 'Self-perceived breast cancer risk vs calculated breast cancer risk', 'timeFrame': '1 year', 'description': "A visual analog scale from 0-100% will be used to compare and assess the self-perceived estimated breast cancer risk with calculated breast cancer risk. 13% is marked as the average cisgender women's risk of breast cancer and participants report their self-perceived risk as single whole integer (ex. 8%, 15%, 25%, etc.) on the scale from 0-100% where 0-12% represents below average risk person and 13-100% represent above average risk."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transgender', 'Gender Diverse', 'Nonbinary', 'Risk Assessment', 'Mastectomy', 'Top Surgery'], 'conditions': ['Breast Cancer', 'Risk Reduction']}, 'referencesModule': {'references': [{'pmid': '39060689', 'type': 'DERIVED', 'citation': 'Cortina CS. ASO Author Reflections: A Breast Cancer Risk Assessment and the Decision for Gender-Affirming Chest Masculinization Surgery or Oncologic Risk-Reducing Mastectomies in Transgender and Gender-Diverse Individuals. Ann Surg Oncol. 2024 Oct;31(11):7483-7484. doi: 10.1245/s10434-024-15801-z. Epub 2024 Jul 26. No abstract available.'}, {'pmid': '38940898', 'type': 'DERIVED', 'citation': 'Cortina CS, Purdy A, Brazauskas R, Stachowiak SM, Fodrocy J, Klement KA, Sasor SE, Krucoff KB, Robertson K, Buth J, Lakatos AEB, Petroll AE, Doren EL. The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals: A Pilot Single-Arm Educational Intervention Trial. Ann Surg Oncol. 2024 Oct;31(11):7474-7482. doi: 10.1245/s10434-024-15701-2. Epub 2024 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment.\n\nThe goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk.\n\nThe results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TGD persons considering chest masculinization surgery.', 'genderDescription': 'Persons who identify as transgender, nonbinary, and/or gender-diverse (TGD) who were assigned female and/or intersex at birth.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years old.\n2. Assigned female or intersex at birth and identify as non-cisgender.\n3. Any individual considering undergoing gender-affirming chest masculinization surgery\n4. Ability to communicate in English.\n5. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. \\<18 years old.\n2. Assigned male sex at birth.\n3. Previously underwent chest masculinization surgery or any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment.\n4. Any previous or current history of breast cancer, including ductal carcina in situ (DCIS).\n5. Inability to communicate in English.'}, 'identificationModule': {'nctId': 'NCT06239766', 'briefTitle': 'BC Risk Assessment Before Top Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons', 'orgStudyIdInfo': {'id': 'PRO00045830'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Cisgender Adults Considering Chest Masculinization Surgery', 'description': 'Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery.', 'interventionNames': ['Diagnostic Test: Breast Cancer Risk Assessment']}], 'interventions': [{'name': 'Breast Cancer Risk Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk', 'armGroupLabels': ['Non-Cisgender Adults Considering Chest Masculinization Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Chandler S Cortina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Chandler S Cortina', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}