ID

26216

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-10-17 11-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00678509

Engels

Eligibility Breast Cancer NCT00678509

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced or recurrent breast cancer
Beschrijving

Advanced breast cancer | Breast cancer recurrent

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

ECOG performance status

Datatype

boolean

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

Life Expectancy

Datatype

boolean

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

HLA-A*2402

Datatype

boolean

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

Laboratory Results

Datatype

boolean

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

Absolute neutrophil count

Datatype

boolean

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

Platelet Count measurement

Datatype

boolean

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

Serum total bilirubin measurement

Datatype

boolean

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

Aspartate aminotransferase measurement

Datatype

boolean

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

Alanine aminotransferase measurement

Datatype

boolean

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

Creatinine measurement, serum

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

Breast Feeding

Datatype

boolean

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

Communicable Disease | Communicable Disease Uncontrolled

Datatype

boolean

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

Steroids | Immunosuppressive Agents

Datatype

boolean

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

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatype

boolean

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

Metastatic malignant neoplasm to brain Uncontrolled | Spinal metastases Uncontrolled

Datatype

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
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT00678509

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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