{
"info": {
"nct_id": "NCT06796348",
"official_title": "Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated with Hemithyroidectomy or Radiofrequency Ablation.",
"inclusion_criteria": "* Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)\n* tumor size of less than 2 cm in all dimensions.\nHealthy volunteers allowed\nMust have minimum age of 30 Years",
"exclusion_criteria": "* suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR\n* tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR\n* if the patient is pregnant OR\n* If the patient is unable to give informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)",
"criterions": [
{
"exact_snippets": "Single tumor in the thyroid gland",
"criterion": "tumor in the thyroid gland",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "tumor"
}
}
]
},
{
"exact_snippets": "FNAB suspecious of cancer",
"criterion": "FNAB result",
"requirements": [
{
"requirement_type": "suspicion of cancer",
"expected_value": true
}
]
},
{
"exact_snippets": "FNAB ... diagnostic of cancer (category V or VI in the Bethesda system)",
"criterion": "FNAB result",
"requirements": [
{
"requirement_type": "diagnostic category",
"expected_value": [
"V",
"VI"
]
}
]
}
]
},
{
"line": "* tumor size of less than 2 cm in all dimensions.",
"criterions": [
{
"exact_snippets": "tumor size of less than 2 cm in all dimensions",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "cm"
}
}
]
}
]
},
{
"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 30 Years",
"criterions": [
{
"exact_snippets": "minimum age of 30 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR",
"criterions": [
{
"exact_snippets": "suspicion of disseminated disease because of PET-positive lymph nodes",
"criterion": "disseminated disease",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "suspect lymph-nodes by ultrasonography (US)",
"criterion": "lymph nodes",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "signs of capsular invasion of the tumor",
"criterion": "capsular invasion of the tumor",
"requirements": [
{
"requirement_type": "signs",
"expected_value": true
}
]
}
]
},
{
"line": "* tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR",
"criterions": [
{
"exact_snippets": "tumor not eligible for RFA treatment because of high-risk location",
"criterion": "tumor location",
"requirements": [
{
"requirement_type": "risk",
"expected_value": "high-risk"
}
]
},
{
"exact_snippets": "previous thyroid surgery",
"criterion": "thyroid surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L )",
"criterion": "hyperparathyroidism",
"requirements": [
{
"requirement_type": "concomitance",
"expected_value": true
}
]
},
{
"exact_snippets": "ionized calcium > 1.32 mmol/L",
"criterion": "ionized calcium",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 1.32,
"unit": "mmol/L"
}
}
]
},
{
"exact_snippets": "PTH > 6 pmol//L",
"criterion": "PTH",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "pmol/L"
}
}
]
}
]
},
{
"line": "* if the patient is pregnant OR",
"criterions": [
{
"exact_snippets": "if the patient is pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* If the patient is unable to give informed consent.",
"criterions": [
{
"exact_snippets": "unable to give informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}