{
"info": {
"nct_id": "NCT05401162",
"official_title": "Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion",
"inclusion_criteria": "1)18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;10)bone marrow function is good,ability to perform stem cell mobilisation and collection.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 60 Years",
"exclusion_criteria": "1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 60 Years",
"criterions": [
{
"exact_snippets": "maximum age of 60 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "maximum age of 60 Years",
"criterion": "age",
"requirement": {
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"operator": "<=",
"value": 60,
"unit": "Years"
}
}
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"exclusion_lines": [
{
"identified_line": {
"line": "1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.",
"criterions": [
{
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"criterion": "bone marrow disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology",
"criterion": "metastases",
"requirement": {
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"expected_value": [
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"soft meningeal",
"bone",
"bone marrow"
]
}
},
{
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{
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"criterion": "cardiac insufficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
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"requirement": {
"requirement_type": "type",
"expected_value": [
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"organ"
]
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},
{
"exact_snippets": "patients with active bleeding and autoimmune thrombocytopenic purpura",
"criterion": "active bleeding",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "patients with active bleeding and autoimmune thrombocytopenic purpura",
"criterion": "autoimmune thrombocytopenic purpura",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients with chemotherapy contraindications",
"criterion": "chemotherapy contraindications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for human immunodeficiency virus (HIV)",
"criterion": "HIV",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "acute or chronic active hepatitis B or hepatitis C infection",
"criterion": "hepatitis infection",
"requirement": {
"requirement_type": "type",
"expected_value": [
"acute",
"chronic active"
]
}
},
{
"exact_snippets": "acute or chronic active hepatitis B or hepatitis C infection",
"criterion": "hepatitis infection",
"requirement": {
"requirement_type": "virus",
"expected_value": [
"hepatitis B",
"hepatitis C"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology",
"criterion": "metastases",
"requirement": {
"requirement_type": "location",
"expected_value": [
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"soft meningeal",
"bone",
"bone marrow"
]
}
},
{
"exact_snippets": "central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology",
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"requirement": {
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"expected_value": [
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]
}
}
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},
{
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "patient has severe cardiac insufficiency",
"criterion": "cardiac insufficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "previous history of allogeneic stem cell transplantation or organ transplantation",
"criterion": "transplantation history",
"requirement": {
"requirement_type": "type",
"expected_value": [
"allogeneic stem cell",
"organ"
]
}
},
{
"and_criteria": [
{
"exact_snippets": "patients with active bleeding and autoimmune thrombocytopenic purpura",
"criterion": "active bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients with active bleeding and autoimmune thrombocytopenic purpura",
"criterion": "autoimmune thrombocytopenic purpura",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "patients with chemotherapy contraindications",
"criterion": "chemotherapy contraindications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for human immunodeficiency virus (HIV)",
"criterion": "HIV",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"and_criteria": [
{
"exact_snippets": "acute or chronic active hepatitis B or hepatitis C infection",
"criterion": "hepatitis infection",
"requirement": {
"requirement_type": "type",
"expected_value": [
"acute",
"chronic active"
]
}
},
{
"exact_snippets": "acute or chronic active hepatitis B or hepatitis C infection",
"criterion": "hepatitis infection",
"requirement": {
"requirement_type": "virus",
"expected_value": [
"hepatitis B",
"hepatitis C"
]
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "1)18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;10)bone marrow function is good,ability to perform stem cell mobilisation and collection.",
"criterions": [
{
"exact_snippets": "18-60 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 60,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "chemotherapy indicators for ovarian cancer",
"criterion": "chemotherapy indicators for ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "ovarian cancer diagnosed by histopathology",
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"requirement": {
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"expected_value": "histopathology"
}
},
{
"exact_snippets": "recurrent and metastatic ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
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"expected_value": [
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"metastatic"
]
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score≤1",
"criterion": "ECOG performance status score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "expected survival time was more than 3 months",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "pre-menopausal women",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "pre-menopausal"
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{
"exact_snippets": "post-menopausal women must have been postmenopausal for at least 12 months",
"criterion": "post-menopausal duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "serum pregnancy test results are negative",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment",
"criterion": "contraceptive measures",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "subjects voluntarily participate in this clinical trial sign an informed consent form",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "able to complete the study procedures and follow-up examinations",
"criterion": "ability to complete study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "bone marrow function is good",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "status",
"expected_value": "good"
}
},
{
"exact_snippets": "ability to perform stem cell mobilisation and collection",
"criterion": "stem cell mobilisation and collection",
"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
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],
"failed_exclusion": [],
"failed_miscellaneous": []
}