ID

26939

Description

CADY Study ICORG 08-01; ODM derived from: https://clinicaltrials.gov/show/NCT00968682

Link

https://clinicaltrials.gov/show/NCT00968682

Keywords

Versions (1)
  1. 10/28/17 10/28/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00968682

English

Eligibility Breast Cancer NCT00968682

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. her-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
Description

HER2-positive carcinoma of breast Immunohistochemistry | HER2-positive carcinoma of breast Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C0162789
2. planned neoadjuvant and/or adjuvant treatment with chemotherapy and trastuzumab either sequentially or in combination or single agent trastuzumab.
Description

Neoadjuvant Chemotherapy Planned | Adjuvant Chemotherapy Planned | trastuzumab | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0009429
3. 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. disease stage i-iii, whose treatment plan includes trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
Description

Disease TNM Breast tumor staging | trastuzumab | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0009429
5. as this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
Description

Study Subject Participation Status | Therapeutic Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1515364
6. treatment with curative intent.
Description

Curative procedure

Data type

boolean

Alias
UMLS CUI [1]
C1276305
7. ecog performance status 0, 1 or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate cardiac function, with muga or echocardiograph > 50%.
Description

Cardiac function MUGA | Cardiac function Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C0013516
9. written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
Description

Medical condition Study Subject Participation Status At risk Patient | Mental condition Study Subject Participation Status At risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0030705
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0030705
2. evidence of metastatic disease.
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
3. patients with uncontrolled hypertension (sustained systolic blood pressure >180mmhg or diastolic blood pressure >100mmhg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Valvular disease | Aortic regurgitation Grade | Mitral regurgitation Grade | Aortic Valve Stenosis | Mitral Valve Stenosis | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction Symptomatic | Myocardial Infarction Asymptomatic | Angina Pectoris Requirement Antianginals

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C3258293
UMLS CUI [5,1]
C0003504
UMLS CUI [5,2]
C0441800
UMLS CUI [6,1]
C0026266
UMLS CUI [6,2]
C0441800
UMLS CUI [7]
C0003507
UMLS CUI [8]
C0026269
UMLS CUI [9,1]
C0003811
UMLS CUI [9,2]
C0205318
UMLS CUI [10,1]
C0027051
UMLS CUI [10,2]
C0231220
UMLS CUI [11,1]
C0027051
UMLS CUI [11,2]
C0231221
UMLS CUI [12,1]
C0002962
UMLS CUI [12,2]
C1514873
UMLS CUI [12,3]
C3537168
4. prior anthracycline or trastuzumab therapy.
Description

Anthracyclines | trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0728747
5. inability to give informed consent for any reason.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT00968682

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HER2-positive carcinoma of breast Immunohistochemistry | HER2-positive carcinoma of breast Fluorescent in Situ Hybridization
Item
1. her-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1960398 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Neoadjuvant Chemotherapy Planned | Adjuvant Chemotherapy Planned | trastuzumab | Combined Modality Therapy
Item
2. planned neoadjuvant and/or adjuvant treatment with chemotherapy and trastuzumab either sequentially or in combination or single agent trastuzumab.
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Age
Item
3. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Disease TNM Breast tumor staging | trastuzumab | Combined Modality Therapy
Item
4. disease stage i-iii, whose treatment plan includes trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Study Subject Participation Status | Therapeutic Clinical Trial
Item
5. as this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
boolean
C2348568 (UMLS CUI [1])
C1515364 (UMLS CUI [2])
Curative procedure
Item
6. treatment with curative intent.
boolean
C1276305 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Cardiac function MUGA | Cardiac function Echocardiography
Item
8. adequate cardiac function, with muga or echocardiograph > 50%.
boolean
C0232164 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Informed Consent
Item
9. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Study Subject Participation Status At risk Patient | Mental condition Study Subject Participation Status At risk Patient
Item
1. presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
Neoplasm Metastasis
Item
2. evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Valvular disease | Aortic regurgitation Grade | Mitral regurgitation Grade | Aortic Valve Stenosis | Mitral Valve Stenosis | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction Symptomatic | Myocardial Infarction Asymptomatic | Angina Pectoris Requirement Antianginals
Item
3. patients with uncontrolled hypertension (sustained systolic blood pressure >180mmhg or diastolic blood pressure >100mmhg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C3258293 (UMLS CUI [4])
C0003504 (UMLS CUI [5,1])
C0441800 (UMLS CUI [5,2])
C0026266 (UMLS CUI [6,1])
C0441800 (UMLS CUI [6,2])
C0003507 (UMLS CUI [7])
C0026269 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0027051 (UMLS CUI [10,1])
C0231220 (UMLS CUI [10,2])
C0027051 (UMLS CUI [11,1])
C0231221 (UMLS CUI [11,2])
C0002962 (UMLS CUI [12,1])
C1514873 (UMLS CUI [12,2])
C3537168 (UMLS CUI [12,3])
Anthracyclines | trastuzumab
Item
4. prior anthracycline or trastuzumab therapy.
boolean
C0282564 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Informed Consent Unable
Item
5. inability to give informed consent for any reason.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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