ID

38004

Beschrijving

Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01433562

Link

https://clinicaltrials.gov/show/NCT01433562

Trefwoorden

Versies (1)
  1. 07-09-19 07-09-19 -
Houder van rechten

See clinicaltrials.gov

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7 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01433562

Engels

Eligibility Breast Cancer NCT01433562

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed stage ii or iii (operable) primary breast cancer
Beschrijving

Breast Carcinoma Operable TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205188
UMLS CUI [1,3]
C0474926
having radiologically evaluable and measurable lesion(s) of the primary tumor
Beschrijving

Lesion Evaluable Radiology | Measurable lesion Radiology | Primary tumor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1516986
UMLS CUI [1,3]
C0043299
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0043299
UMLS CUI [3]
C0677930
karnofsky performance status 80 %
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
normal cardiac function: lvef > 50 %
Beschrijving

Cardiac function | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
adequate hematological function: hb ≥ 10.0 g/dl, wbc ≥ 3,000/mm3, anc ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3
Beschrijving

Hematologic function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
adequate liver function: alt ≤ 2.5 times upper limit of normal, total bilirubin level
Beschrijving

Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
≤ 1.5 times upper limit of normal
Beschrijving

ID.7

Datatype

boolean

adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
able to take oral medication
Beschrijving

Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast feeding subjects
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of previous breast cancer (recurrent breast cancer)
Beschrijving

Breast Carcinoma Previous | Breast cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0278493
history of other cancer within the past 5 years
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
prior systemic treatment for the current breast cancer
Beschrijving

Systemic therapy Previous Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0678222
prior preoperative topical treatments for the current breast cancer
Beschrijving

Neoadjuvant Therapy Topical Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0332237
UMLS CUI [1,3]
C0678222
uncontrolled or serious cvd
Beschrijving

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205404
known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study
Beschrijving

Hypersensitivity Chemotherapeutic agent Clinical Trial | Hypersensitivity Suspected Chemotherapeutic agent Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0729502
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0729502
UMLS CUI [2,4]
C0008976
any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation
Beschrijving

Disease Serious Interferes with Study Subject Participation Status | Medical condition Serious Interferes with Study Subject Participation Status | Disease Serious Interferes with Evaluation | Medical condition Serious Interferes with Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1261322
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1261322
concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening
Beschrijving

Herbal medicine Effect Breast Carcinoma | Dietary Supplements Effect Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C2240391
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0678222
severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
Beschrijving

Severe Mental Disorders Exclude Informed Consent | Nervous system disorder Excludes Informed Consent | Dementia Excludes Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0021430
participation in any other clinical studies within 30 days prior to screening
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Breast Cancer NCT01433562

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Operable TNM Breast tumor staging
Item
confirmed stage ii or iii (operable) primary breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Lesion Evaluable Radiology | Measurable lesion Radiology | Primary tumor
Item
having radiologically evaluable and measurable lesion(s) of the primary tumor
boolean
C0221198 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3])
Karnofsky Performance Status
Item
karnofsky performance status 80 %
boolean
C0206065 (UMLS CUI [1])
Cardiac function | Left ventricular ejection fraction
Item
normal cardiac function: lvef > 50 %
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Hematologic function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
adequate hematological function: hb ≥ 10.0 g/dl, wbc ≥ 3,000/mm3, anc ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3
boolean
C0221130 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
adequate liver function: alt ≤ 2.5 times upper limit of normal, total bilirubin level
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
ID.7
Item
≤ 1.5 times upper limit of normal
boolean
Renal function | Creatinine measurement, serum
Item
adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Able to swallow Oral medication
Item
able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Breast Carcinoma Previous | Breast cancer recurrent
Item
history of previous breast cancer (recurrent breast cancer)
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
Cancer Other
Item
history of other cancer within the past 5 years
boolean
C1707251 (UMLS CUI [1])
Systemic therapy Previous Breast Carcinoma
Item
prior systemic treatment for the current breast cancer
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Neoadjuvant Therapy Topical Breast Carcinoma
Item
prior preoperative topical treatments for the current breast cancer
boolean
C0600558 (UMLS CUI [1,1])
C0332237 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Serious
Item
uncontrolled or serious cvd
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Hypersensitivity Chemotherapeutic agent Clinical Trial | Hypersensitivity Suspected Chemotherapeutic agent Clinical Trial
Item
known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study
boolean
C0020517 (UMLS CUI [1,1])
C0729502 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0729502 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Disease Serious Interferes with Study Subject Participation Status | Medical condition Serious Interferes with Study Subject Participation Status | Disease Serious Interferes with Evaluation | Medical condition Serious Interferes with Evaluation
Item
any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1261322 (UMLS CUI [4,4])
Herbal medicine Effect Breast Carcinoma | Dietary Supplements Effect Breast Carcinoma
Item
concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening
boolean
C2240391 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Severe Mental Disorders Exclude Informed Consent | Nervous system disorder Excludes Informed Consent | Dementia Excludes Informed Consent
Item
severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
boolean
C4046029 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Study Subject Participation Status
Item
participation in any other clinical studies within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
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