{
    "info": {
        "nct_id": "NCT06518382",
        "official_title": "A Retrospective Observational Study Characterizing Tumour-microenvironment Spatial Interaction Aimed at the Identification of New Markers of Resistance to Therapy in HER2-positive Breast Cancer Patients",
        "inclusion_criteria": "1. Participant is willing and able to give informed consent for participation in the study.\n2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC/EC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab.\n3. Specimen collected at surgery display residual invasive disease in the breast/lymph node.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. pre-existing conditions or concurrent diagnoses;\n2. concomitant use of other medications during neo-adjuvant treatment;\n3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Participant is willing and able to give informed consent for participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant is willing ... to give informed consent",
                    "criterion": "willingness to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant is ... able to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC/EC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab.",
            "criterions": [
                {
                    "exact_snippets": "biopsy",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sequential chemotherapy comprising treatment with antracyclines (AC/EC q21, 4 cycles)",
                    "criterion": "sequential chemotherapy with antracyclines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taxanes (paclitaxel 1,8,15 q21 for 12 weeks)",
                    "criterion": "taxanes (paclitaxel)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-HER2 antibody trastuzumab",
                    "criterion": "anti-HER2 antibody trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Specimen collected at surgery display residual invasive disease in the breast/lymph node.",
            "criterions": [
                {
                    "exact_snippets": "Specimen collected at surgery display residual invasive disease in the breast",
                    "criterion": "residual invasive disease in the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Specimen collected at surgery display residual invasive disease in the ... lymph node",
                    "criterion": "residual invasive disease in the lymph node",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. pre-existing conditions or concurrent diagnoses;",
            "criterions": [
                {
                    "exact_snippets": "pre-existing conditions",
                    "criterion": "pre-existing conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent diagnoses",
                    "criterion": "concurrent diagnoses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. concomitant use of other medications during neo-adjuvant treatment;",
            "criterions": [
                {
                    "exact_snippets": "concomitant use of other medications during neo-adjuvant treatment",
                    "criterion": "concomitant use of other medications",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during neo-adjuvant treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.",
            "criterions": [
                {
                    "exact_snippets": "quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis",
                    "criterion": "quality of stored specimen",
                    "requirements": [
                        {
                            "requirement_type": "standard compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}