{
"info": {
"nct_id": "NCT03112694",
"official_title": "A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors",
"inclusion_criteria": "* Males and females age 18 years or older at time of locally advanced or metastatic diagnosis\n* Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)\n* Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients with other malignant disease\n* Patients who participated in a concomitant clinical trial related to treatment of GEP-NET\n* Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#\n* Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide\n* Patients with NET familial genetic syndrome (i.e., MEN1)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Males and females age 18 years or older at time of locally advanced or metastatic diagnosis",
"criterions": [
{
"exact_snippets": "Males and females",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "age 18 years or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "locally advanced or metastatic diagnosis",
"criterion": "diagnosis stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
]
}
]
},
{
"line": "* Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)",
"criterions": [
{
"exact_snippets": "confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)",
"criterion": "Gastroenteropancreatic neuroendocrine tumour (GEP-NET)",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
},
{
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
]
}
]
},
{
"line": "* Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)",
"criterions": [
{
"exact_snippets": "Patients who switched treatment from long acting octreotide LAR to lanreotide",
"criterion": "treatment switch",
"requirements": [
{
"requirement_type": "from",
"expected_value": "long acting octreotide LAR"
},
{
"requirement_type": "to",
"expected_value": "lanreotide"
}
]
},
{
"exact_snippets": "both treatments were received for the treatment of locally advanced or metastatic GEP-NET",
"criterion": "treatment purpose",
"requirements": [
{
"requirement_type": "condition",
"expected_value": [
"locally advanced GEP-NET",
"metastatic GEP-NET"
]
}
]
},
{
"exact_snippets": "Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy",
"criterion": "treatment duration",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "long acting octreotide LAR monotherapy"
},
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "days"
}
},
{
"requirement_type": "sequence",
"expected_value": "before treatment with lanreotide monotherapy"
}
]
},
{
"exact_snippets": "Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy",
"criterion": "treatment duration",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "lanreotide monotherapy"
},
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "days"
}
},
{
"requirement_type": "sequence",
"expected_value": "after treatment with long acting octreotide monotherapy"
}
]
}
]
},
{
"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": "* Patients with other malignant disease",
"criterions": [
{
"exact_snippets": "Patients with other malignant disease",
"criterion": "other malignant disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients who participated in a concomitant clinical trial related to treatment of GEP-NET",
"criterions": [
{
"exact_snippets": "Patients who participated in a concomitant clinical trial",
"criterion": "participation in a concomitant clinical trial",
"requirements": [
{
"requirement_type": "related to",
"expected_value": "treatment of GEP-NET"
}
]
}
]
},
{
"line": "* Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#",
"criterions": [
{
"exact_snippets": "Patients being treated with a Somatostatin analogue (SSA)",
"criterion": "Somatostatin analogue (SSA) treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "in combination with other NET treatments",
"criterion": "NET treatments",
"requirements": [
{
"requirement_type": "combination with SSA",
"expected_value": true
}
]
},
{
"exact_snippets": "excluding rescue SSA",
"criterion": "rescue SSA",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide",
"criterions": [
{
"exact_snippets": "Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET",
"criterion": "primary treatment for GEP-NET",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "during the interval between octreotide and lanreotide",
"criterion": "treatment interval",
"requirements": [
{
"requirement_type": "specific interval",
"expected_value": "between octreotide and lanreotide"
}
]
}
]
},
{
"line": "* Patients with NET familial genetic syndrome (i.e., MEN1)",
"criterions": [
{
"exact_snippets": "NET familial genetic syndrome (i.e., MEN1)",
"criterion": "NET familial genetic syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "MEN1",
"criterion": "MEN1",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}