{
"info": {
"nct_id": "NCT06057220",
"official_title": "Investigation of Immune Pathways and Microbiome Disruption as Drivers of Mutagenesis in Oesophagogastric Cancer",
"inclusion_criteria": "1. Adult patients >16 years old\n2. Referred for oesophago-gastro-duodenoscopy (OGD) to investigate any of the following;\n\n 1. Symptoms including difficulty swallowing, vomiting, reflux symptoms including heartburn, anaemia, GI bleeding, upper abdominal pain and weight loss.\n 2. Oesophagitis, gastritis or GORD.\n 3. Barrett's oesophagus (BO) requiring surveillance or endoscopic therapy.\n3. Histologically confirmed OGc undergoing further investigation as part of staging such as laparoscopy and OGD or undergoing surgical resection (oesophagectomy/gastrectomy) as part of their treatment.\nHealthy volunteers allowed\nMust have minimum age of 17 Years",
"exclusion_criteria": "1. Cancers other than adenocarcinoma or squamous cell carcinoma, including but not limited to gastro-intestinal stromal tumours (GIST), mucosa associated lymphoid tissue lymphoma (MALT lymphoma) and carcinoid tumours.\n2. Patients with recurrent OGc.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Adult patients >16 years old",
"criterions": [
{
"exact_snippets": "Adult patients >16 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 16,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. Referred for oesophago-gastro-duodenoscopy (OGD) to investigate any of the following;",
"criterions": [
{
"exact_snippets": "Referred for oesophago-gastro-duodenoscopy (OGD)",
"criterion": "oesophago-gastro-duodenoscopy (OGD)",
"requirements": [
{
"requirement_type": "referral",
"expected_value": true
}
]
}
]
},
{
"line": "1. Symptoms including difficulty swallowing, vomiting, reflux symptoms including heartburn, anaemia, GI bleeding, upper abdominal pain and weight loss.",
"criterions": [
{
"exact_snippets": "difficulty swallowing",
"criterion": "difficulty swallowing",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "vomiting",
"criterion": "vomiting",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "reflux symptoms including heartburn",
"criterion": "reflux symptoms",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "anaemia",
"criterion": "anaemia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "GI bleeding",
"criterion": "GI bleeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "upper abdominal pain",
"criterion": "upper abdominal pain",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "weight loss",
"criterion": "weight loss",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "2. Oesophagitis, gastritis or GORD.",
"criterions": [
{
"exact_snippets": "Oesophagitis",
"criterion": "oesophagitis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "gastritis",
"criterion": "gastritis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "GORD",
"criterion": "GORD",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Barrett's oesophagus (BO) requiring surveillance or endoscopic therapy.",
"criterions": [
{
"exact_snippets": "Barrett's oesophagus (BO)",
"criterion": "Barrett's oesophagus",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "requiring surveillance or endoscopic therapy",
"criterion": "surveillance or endoscopic therapy",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "3. Histologically confirmed OGc undergoing further investigation as part of staging such as laparoscopy and OGD or undergoing surgical resection (oesophagectomy/gastrectomy) as part of their treatment.",
"criterions": [
{
"exact_snippets": "Histologically confirmed OGc",
"criterion": "OGc (Oesophagogastric cancer)",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "undergoing further investigation as part of staging such as laparoscopy and OGD",
"criterion": "further investigation",
"requirements": [
{
"requirement_type": "purpose",
"expected_value": "staging"
},
{
"requirement_type": "methods",
"expected_value": [
"laparoscopy",
"OGD"
]
}
]
},
{
"exact_snippets": "undergoing surgical resection (oesophagectomy/gastrectomy) as part of their treatment",
"criterion": "surgical resection",
"requirements": [
{
"requirement_type": "procedures",
"expected_value": [
"oesophagectomy",
"gastrectomy"
]
},
{
"requirement_type": "purpose",
"expected_value": "treatment"
}
]
}
]
},
{
"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 17 Years",
"criterions": [
{
"exact_snippets": "minimum age of 17 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 17,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Cancers other than adenocarcinoma or squamous cell carcinoma, including but not limited to gastro-intestinal stromal tumours (GIST), mucosa associated lymphoid tissue lymphoma (MALT lymphoma) and carcinoid tumours.",
"criterions": [
{
"exact_snippets": "Cancers other than adenocarcinoma or squamous cell carcinoma",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"adenocarcinoma",
"squamous cell carcinoma"
]
}
]
},
{
"exact_snippets": "gastro-intestinal stromal tumours (GIST)",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": "gastro-intestinal stromal tumours (GIST)"
}
]
},
{
"exact_snippets": "mucosa associated lymphoid tissue lymphoma (MALT lymphoma)",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": "mucosa associated lymphoid tissue lymphoma (MALT lymphoma)"
}
]
},
{
"exact_snippets": "carcinoid tumours",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": "carcinoid tumours"
}
]
}
]
},
{
"line": "2. Patients with recurrent OGc.",
"criterions": [
{
"exact_snippets": "recurrent OGc",
"criterion": "OGc",
"requirements": [
{
"requirement_type": "recurrence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}