{
"info": {
"nct_id": "NCT06239766",
"official_title": "Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons",
"inclusion_criteria": "1. ≥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.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. <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.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. ≥18 years old.",
"criterions": [
{
"exact_snippets": "≥18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "≥18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Assigned female or intersex at birth and identify as non-cisgender.",
"criterions": [
{
"exact_snippets": "Assigned female or intersex at birth",
"criterion": "sex assigned at birth",
"requirement": {
"requirement_type": "value",
"expected_value": [
"female",
"intersex"
]
}
},
{
"exact_snippets": "identify as non-cisgender",
"criterion": "gender identity",
"requirement": {
"requirement_type": "value",
"expected_value": "non-cisgender"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Assigned female or intersex at birth",
"criterion": "sex assigned at birth",
"requirement": {
"requirement_type": "value",
"expected_value": [
"female",
"intersex"
]
}
},
{
"exact_snippets": "identify as non-cisgender",
"criterion": "gender identity",
"requirement": {
"requirement_type": "value",
"expected_value": "non-cisgender"
}
}
]
}
},
{
"identified_line": {
"line": "3. Any individual considering undergoing gender-affirming chest masculinization surgery",
"criterions": [
{
"exact_snippets": "considering undergoing gender-affirming chest masculinization surgery",
"criterion": "gender-affirming chest masculinization surgery",
"requirement": {
"requirement_type": "consideration",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "considering undergoing gender-affirming chest masculinization surgery",
"criterion": "gender-affirming chest masculinization surgery",
"requirement": {
"requirement_type": "consideration",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Ability to communicate in English.",
"criterions": [
{
"exact_snippets": "Ability to communicate in English",
"criterion": "English communication ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to communicate in English",
"criterion": "English communication ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Ability to understand a written informed consent document, and the willingness to sign it.",
"criterions": [
{
"exact_snippets": "Ability to understand a written informed consent document",
"criterion": "understanding of informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign it",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to understand a written informed consent document",
"criterion": "understanding of informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign it",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. <18 years old.",
"criterions": [
{
"exact_snippets": "<18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "<18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Assigned male sex at birth.",
"criterions": [
{
"exact_snippets": "Assigned male sex at birth",
"criterion": "sex at birth",
"requirement": {
"requirement_type": "assigned sex",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Assigned male sex at birth",
"criterion": "sex at birth",
"requirement": {
"requirement_type": "assigned sex",
"expected_value": "male"
}
}
}
},
{
"identified_line": {
"line": "3. Previously underwent chest masculinization surgery or any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment.",
"criterions": [
{
"exact_snippets": "Previously underwent chest masculinization surgery",
"criterion": "chest masculinization surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment",
"criterion": "oncological mastectomy",
"requirement": {
"requirement_type": "purpose",
"expected_value": [
"risk-reduction",
"cancer treatment"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Previously underwent chest masculinization surgery",
"criterion": "chest masculinization surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment",
"criterion": "oncological mastectomy",
"requirement": {
"requirement_type": "purpose",
"expected_value": [
"risk-reduction",
"cancer treatment"
]
}
}
]
}
},
{
"identified_line": {
"line": "4. Any previous or current history of breast cancer, including ductal carcina in situ (DCIS).",
"criterions": [
{
"exact_snippets": "previous or current history of breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "ductal carcina in situ (DCIS)",
"criterion": "ductal carcinoma in situ (DCIS)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "previous or current history of breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "ductal carcina in situ (DCIS)",
"criterion": "ductal carcinoma in situ (DCIS)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Inability to communicate in English.",
"criterions": [
{
"exact_snippets": "Inability to communicate in English",
"criterion": "ability to communicate in English",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Inability to communicate in English",
"criterion": "ability to communicate in English",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}