{
    "info": {
        "nct_id": "NCT02973672",
        "official_title": "A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Colorectal Cancer or Pancreatic Cancer",
        "inclusion_criteria": "* Patients aged over 18 years old;\n* Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas;\n* Both pancreatic and colorectal cancer patients: Circulating plasma CEA ≥ the upper limit of normal range (eg ≥ 3.0 ng / ml);\n* Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA\n* Patients should be capable and willing to give informed consent before study specific procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;\n* History of a clinically significant allergy;\n* Circulating plasma concentration CEA ≥ 300 ng / ml;\n* Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;\n* Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;\n* Laboratory abnormalities defined as:\n\nColorectal cancer patients only:\n\n* Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;\n* Total bilirubin above 2 times the Upper Limit Normal (ULN) or; Both pancreatic and colorectal cancer patients:\n* Serum creatinine above 1.5 times the ULN or;\n* Absolute neutrophils counts below 1.5 x 109/L or;\n* Platelet count below 100 x 109/L or;\n* Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);\n* Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;\n* Any condition that the investigator considers to be potentially jeopardizing the patients' wellbeing or the study objectives.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients aged over 18 years old;",
            "criterions": [
                {
                    "exact_snippets": "Patients aged over 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas;",
            "criterions": [
                {
                    "exact_snippets": "eligible for surgery",
                    "criterion": "surgery eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical diagnosis of cancer of the colon",
                    "criterion": "colon cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical diagnosis of ... rectum",
                    "criterion": "rectal cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical diagnosis of ... cancer of the pancreas",
                    "criterion": "pancreatic cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both pancreatic and colorectal cancer patients: Circulating plasma CEA ≥ the upper limit of normal range (eg ≥ 3.0 ng / ml);",
            "criterions": [
                {
                    "exact_snippets": "pancreatic and colorectal cancer patients",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "pancreatic",
                                "colorectal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Circulating plasma CEA ≥ the upper limit of normal range (eg ≥ 3.0 ng / ml)",
                    "criterion": "circulating plasma CEA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA",
            "criterions": [
                {
                    "exact_snippets": "recurrences and metastasis of colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "recurrences and metastasis"
                        }
                    ]
                },
                {
                    "exact_snippets": "Rising circulating plasma CEA",
                    "criterion": "circulating plasma CEA",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should be capable and willing to give informed consent before study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "capable and willing to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "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 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": "* Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;",
            "criterions": [
                {
                    "exact_snippets": "Anticancer therapy (e.g. chemotherapy, radiotherapy ... targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of a clinically significant allergy;",
            "criterions": [
                {
                    "exact_snippets": "History of a clinically significant allergy",
                    "criterion": "clinically significant allergy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Circulating plasma concentration CEA ≥ 300 ng / ml;",
            "criterions": [
                {
                    "exact_snippets": "Circulating plasma concentration CEA ≥ 300 ng / ml",
                    "criterion": "circulating plasma concentration CEA",
                    "requirements": [
                        {
                            "requirement_type": "concentration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 300,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies either currently active",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other malignancies ... diagnosed in the last 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... basal or squamous cell skin carcinoma",
                    "criterion": "basal or squamous cell skin carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;",
            "criterions": [
                {
                    "exact_snippets": "Patients pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4±1 weeks prior to administration of the conjugate"
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of effective contraception in male or female patients with reproductive potential",
                    "criterion": "effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Colorectal cancer patients only:",
            "criterions": [
                {
                    "exact_snippets": "Colorectal cancer patients only",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;",
            "criterions": [
                {
                    "exact_snippets": "Aspartate AminoTransferase ... levels above 5 times the",
                    "criterion": "Aspartate AminoTransferase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine AminoTransferase ... levels above 5 times the",
                    "criterion": "Alanine AminoTransferase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gamma Glutamyl Transferase ... levels above 5 times the",
                    "criterion": "Gamma Glutamyl Transferase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline Phosphatase levels above 5 times the",
                    "criterion": "Alkaline Phosphatase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin above 2 times the Upper Limit Normal (ULN) or; Both pancreatic and colorectal cancer patients:",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin above 2 times the Upper Limit Normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic and colorectal cancer patients",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "pancreatic",
                                "colorectal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine above 1.5 times the ULN or;",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine above 1.5 times the ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophils counts below 1.5 x 109/L or;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophils counts below 1.5 x 109/L",
                    "criterion": "absolute neutrophils counts",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count below 100 x 109/L or;",
            "criterions": [
                {
                    "exact_snippets": "Platelet count below 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin below 4 mmol/L (females)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ... below 5 mmol/l (males)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;",
            "criterions": [
                {
                    "exact_snippets": "Known positive test for human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known positive test for ... hepatitis B surface antigen (HBsAG)",
                    "criterion": "hepatitis B surface antigen (HBsAG) status",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known positive test for ... hepatitis C virus (HCV) antibody",
                    "criterion": "hepatitis C virus (HCV) antibody status",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with untreated serious infections",
                    "criterion": "serious infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that the investigator considers to be potentially jeopardizing the patients' wellbeing or the study objectives.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing the patients' wellbeing or the study objectives.",
                    "criterion": "condition jeopardizing wellbeing or study objectives",
                    "requirements": [
                        {
                            "requirement_type": "investigator consideration",
                            "expected_value": "potentially jeopardizing"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Laboratory abnormalities defined as:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}