ID

26089

Description

Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting; ODM derived from: https://clinicaltrials.gov/show/NCT00618657

Link

https://clinicaltrials.gov/show/NCT00618657

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00618657

English

Eligibility Breast Cancer NCT00618657

1 forms  
Criteria
Description

Criteria

physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration
Description

Neoplasm Assessment Physical Examination | Neoplasm Assessment Scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0441633
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible
Description

Congestive heart failure Exclusion | Angina Pectoris Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C2828389
serum creatinine within normal limits within 90 days prior to registration
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin within normal limits within 90 days prior to registration
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum glutamic oxaloacetic transaminase (sgot) or serum glutamate pyruvate transaminase (sgpt) =< 2 x the institutional upper limit of normal within 90 days prior to registration
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
absolute neutrophil count (anc) of >= 1,500/microliters within 90 days prior to registration
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count of >= 100,000/microliters within 90 days prior to registration
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
patients must have a performance status of 0-2 by zubrod criteria
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential
Description

Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a monday, the monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
Description

Tests | Measurement | Schedules, Patient

Data type

boolean

Alias
UMLS CUI [1]
C0392366
UMLS CUI [2]
C0242485
UMLS CUI [3]
C0030703
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Breast Cancer NCT00618657

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Neoplasm Assessment Physical Examination | Neoplasm Assessment Scanning
Item
physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration
boolean
C0027651 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0441633 (UMLS CUI [2,3])
Congestive heart failure Exclusion | Angina Pectoris Exclusion
Item
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible
boolean
C0018802 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
serum creatinine within normal limits within 90 days prior to registration
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin within normal limits within 90 days prior to registration
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum glutamic oxaloacetic transaminase (sgot) or serum glutamate pyruvate transaminase (sgpt) =< 2 x the institutional upper limit of normal within 90 days prior to registration
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) of >= 1,500/microliters within 90 days prior to registration
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count of >= 100,000/microliters within 90 days prior to registration
boolean
C0032181 (UMLS CUI [1])
Zubrod Performance Status
Item
patients must have a performance status of 0-2 by zubrod criteria
boolean
C3714786 (UMLS CUI [1])
Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test
Item
pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
Tests | Measurement | Schedules, Patient
Item
in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a monday, the monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
boolean
C0392366 (UMLS CUI [1])
C0242485 (UMLS CUI [2])
C0030703 (UMLS CUI [3])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
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