ID

35072

Beschrijving

Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide; ODM derived from: https://clinicaltrials.gov/show/NCT02502864

Link

https://clinicaltrials.gov/show/NCT02502864

Trefwoorden

Versies (1)
  1. 13-02-19 13-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02502864

Engels

Eligibility Breast Cancer NCT02502864

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard tc (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)
Beschrijving

Breast Carcinoma Localized | Locally advanced breast cancer | Chemotherapy cycle Quantity TC | docetaxel | Cyclophosphamide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0392752
UMLS CUI [2]
C3495949
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C4522122
UMLS CUI [4]
C0246415
UMLS CUI [5]
C0010583
age >/= 65 years (senior adult focused study given increased risk for toxicity)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
participants must be female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
eastern cooperative oncology group (ecog) performance status <2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
must have normal organ and marrow function
Beschrijving

Organ function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
no pre-existing neuropathy grade > 1 per the nci common toxicity criteria for adverse effects (ctcae) version 4.0
Beschrijving

Absence Neuropathy Pre-existing CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0442874
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C1516728
be postmenopausal (defined as amenorrheic for at least 12 months)
Beschrijving

Postmenopausal state | Amenorrhea Duration

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with institutional guidelines and good clinical practice (gcp) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
Beschrijving

Illness Uncontrolled Limiting Protocol Compliance | Communicable Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0525058
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0003811
have psychiatric illness that would limit compliance with study requirements
Beschrijving

Mental disorders Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
Beschrijving

Allergic Reaction Compound Taxanes Similar | Allergic Reaction Docetaxel | Paclitaxel allergy | Allergic Reaction Compound Cyclophosphamide Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0796419
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0246415
UMLS CUI [3]
C0570707
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C0010583
UMLS CUI [4,4]
C2348205
have known seropositivity for human immunodeficiency virus, hepatitis c virus, hepatitis b surface antigen, or syphilis. does not require serologic confirmation as a study procedure.
Beschrijving

HIV Seropositivity | Hepatitis C virus Seropositive | Hepatitis B Surface Antigens Seropositive | Syphilis

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4]
C0039128
not willing to follow protocol requirements or to give informed consent
Beschrijving

Protocol Compliance Unwilling | Informed Consent Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Breast Cancer NCT02502864

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Localized | Locally advanced breast cancer | Chemotherapy cycle Quantity TC | docetaxel | Cyclophosphamide
Item
must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard tc (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)
boolean
C0678222 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C4522122 (UMLS CUI [3,3])
C0246415 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
Age
Item
age >/= 65 years (senior adult focused study given increased risk for toxicity)
boolean
C0001779 (UMLS CUI [1])
Gender
Item
participants must be female
boolean
C0079399 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status <2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absence Neuropathy Pre-existing CTCAE Grades
Item
no pre-existing neuropathy grade > 1 per the nci common toxicity criteria for adverse effects (ctcae) version 4.0
boolean
C0332197 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
Postmenopausal state | Amenorrhea Duration
Item
be postmenopausal (defined as amenorrheic for at least 12 months)
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Informed Consent
Item
must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with institutional guidelines and good clinical practice (gcp) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness Uncontrolled Limiting Protocol Compliance | Communicable Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia
Item
have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Mental disorders Limiting Protocol Compliance
Item
have psychiatric illness that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Allergic Reaction Compound Taxanes Similar | Allergic Reaction Docetaxel | Paclitaxel allergy | Allergic Reaction Compound Cyclophosphamide Similar
Item
have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0796419 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0570707 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0010583 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
HIV Seropositivity | Hepatitis C virus Seropositive | Hepatitis B Surface Antigens Seropositive | Syphilis
Item
have known seropositivity for human immunodeficiency virus, hepatitis c virus, hepatitis b surface antigen, or syphilis. does not require serologic confirmation as a study procedure.
boolean
C0019699 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0039128 (UMLS CUI [4])
Protocol Compliance Unwilling | Informed Consent Unwilling
Item
not willing to follow protocol requirements or to give informed consent
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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