ID

26216

Description

Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00678509

Link

https://clinicaltrials.gov/show/NCT00678509

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00678509

English

Eligibility Breast Cancer NCT00678509

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced or recurrent breast cancer
Description

Advanced breast cancer | Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C3495917
UMLS CUI [2]
C0278493
resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
Description

Resistant to Chemotherapy Anthracycline based | Resistant to Chemotherapy Taxane based | Chemotherapy Continue Difficult | Adverse effects Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0282564
UMLS CUI [1,4]
C1705938
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0215136
UMLS CUI [2,4]
C1705938
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0549178
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C1883420
resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
Description

Resistant to trastuzumab | Trastuzumab Continue Difficult | HER2/Neu Positive Adverse effects Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C0332218
UMLS CUI [3,1]
C2348909
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C1883420
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
hla-a*2402
Description

HLA-A*2402

Data type

boolean

Alias
UMLS CUI [1]
C1098634
laboratory values as follows
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
2000/mm3<wbc<15000/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count>100000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 3.0mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
asparate transaminase < 150iu/l
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
alanine transaminase < 150iu/l
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
creatinine < 3.0mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
able and willing to give valid written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception)
Description

Pregnancy | Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1705116
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
active or uncontrolled infection
Description

Communicable Disease | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
concurrent treatment with steroids or immunosuppressing agent
Description

Steroids | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
uncontrolled brain and/or intraspinal
Description

Metastatic malignant neoplasm to brain Uncontrolled | Spinal metastases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0684550
UMLS CUI [2,2]
C0205318
decision of unsuitableness by principal investigator or physician-in-charge
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00678509

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Advanced breast cancer | Breast cancer recurrent
Item
advanced or recurrent breast cancer
boolean
C3495917 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Resistant to Chemotherapy Anthracycline based | Resistant to Chemotherapy Taxane based | Chemotherapy Continue Difficult | Adverse effects Unacceptable
Item
resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
boolean
C0332325 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C1705938 (UMLS CUI [1,4])
C0332325 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0215136 (UMLS CUI [2,3])
C1705938 (UMLS CUI [2,4])
C0392920 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0879626 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
Resistant to trastuzumab | Trastuzumab Continue Difficult | HER2/Neu Positive Adverse effects Unacceptable
Item
resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
boolean
C0332325 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C2348909 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C1883420 (UMLS CUI [3,3])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
HLA-A*2402
Item
hla-a*2402
boolean
C1098634 (UMLS CUI [1])
Laboratory Results
Item
laboratory values as follows
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
2000/mm3<wbc<15000/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count>100000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 3.0mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
asparate transaminase < 150iu/l
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine transaminase < 150iu/l
boolean
C0201836 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 3.0mg/dl
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
able and willing to give valid written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable
Item
pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Communicable Disease | Communicable Disease Uncontrolled
Item
active or uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Steroids | Immunosuppressive Agents
Item
concurrent treatment with steroids or immunosuppressing agent
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Metastatic malignant neoplasm to brain Uncontrolled | Spinal metastases Uncontrolled
Item
uncontrolled brain and/or intraspinal
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0684550 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
decision of unsuitableness by principal investigator or physician-in-charge
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial