ID

16261

Beschrijving

Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193115

Link

https://clinicaltrials.gov/show/NCT00193115

Trefwoorden

Versies (1)
  1. 08-07-16 08-07-16 -
Geüploaded op

8 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00193115

Engels

Eligibility Breast Cancer NCT00193115

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Beschrijving

ID.1

Datatype

boolean

histologically proven breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
females, age greater than 18 years
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ability to perform activites of daily living with minimal assistance
Beschrijving

Performance of activities of daily living Ability | Assistance Minimal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1821398
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0557034
UMLS CUI [2,2]
C0547040
normal cardiac function
Beschrijving

Cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
adequate bone marrow, liver and kidney
Beschrijving

Bone Marrow function | Liver function | Normal renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232805
signed informed consent prior to beginning specific protocol procedures
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
prior systemic anticancer therapy for breast cancer
Beschrijving

cancer treatment Systemic Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0678222
prior anthracycline or taxane based chemotherapy for any malignancy
Beschrijving

Anthracyclines Chemotherapy Malignant Neoplasms | Taxanes Chemotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C0796419
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0006826
pregnant or breast-feeding women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pre-existing moderate to severe motor or sensory neurotoxicity
Beschrijving

Toxicity Motor nerve Moderate to severe Pre-existing | Toxicity Sensory nerve Moderate to severe Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0501384
UMLS CUI [1,3]
C1299393
UMLS CUI [1,4]
C2347662
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0501385
UMLS CUI [2,3]
C1299393
UMLS CUI [2,4]
C2347662
other serious illness or medical condition
Beschrijving

Illness Serious | Other medical condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

criteria Additional | Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2]
C2348568
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Similar models

Eligibility Breast Cancer NCT00193115

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
to be included in this study, you must meet the following criteria:
boolean
Breast Carcinoma
Item
histologically proven breast cancer
boolean
C0678222 (UMLS CUI [1])
Gender | Age
Item
females, age greater than 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Performance of activities of daily living Ability | Assistance Minimal
Item
ability to perform activites of daily living with minimal assistance
boolean
C1821398 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0557034 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
Cardiac function
Item
normal cardiac function
boolean
C0232164 (UMLS CUI [1])
Bone Marrow function | Liver function | Normal renal function
Item
adequate bone marrow, liver and kidney
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232805 (UMLS CUI [3])
Informed consent
Item
signed informed consent prior to beginning specific protocol procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
you cannot participate in this study if any of the following apply to you:
boolean
C2348568 (UMLS CUI [1])
cancer treatment Systemic Breast Carcinoma
Item
prior systemic anticancer therapy for breast cancer
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Anthracyclines Chemotherapy Malignant Neoplasms | Taxanes Chemotherapy Malignant Neoplasms
Item
prior anthracycline or taxane based chemotherapy for any malignancy
boolean
C0282564 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0796419 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Toxicity Motor nerve Moderate to severe Pre-existing | Toxicity Sensory nerve Moderate to severe Pre-existing
Item
pre-existing moderate to severe motor or sensory neurotoxicity
boolean
C0600688 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C1299393 (UMLS CUI [1,3])
C2347662 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C0501385 (UMLS CUI [2,2])
C1299393 (UMLS CUI [2,3])
C2347662 (UMLS CUI [2,4])
Illness Serious | Other medical condition Serious
Item
other serious illness or medical condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
criteria Additional | Study Subject Participation Status
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
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