ID

43585

Description

Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2; ODM derived from: https://clinicaltrials.gov/show/NCT00363012

Link

https://clinicaltrials.gov/show/NCT00363012

Keywords

  1. 1/13/17 1/13/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00363012

Eligibility Breast Cancer NCT00363012

Criteria
Description

Criteria

diagnosis of stage iii/iv breast cancer
Description

Breast Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
completed chemotherapy
Description

Chemotherapy Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
receiving trastuzumab (herceptin®) monotherapy
Description

trastuzumab | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C0338204
successful completion of her-2/neu (her2) intracellular domain (icd) plasmid-based vaccine trial (protocol 01-9773-d06: "a phase i safety and efficacy trial of a dna plasmid based vaccine encoding the her-2/neu intracellular domain in subjects with her-2/neu-overexpressing tumors") within the past 3 months
Description

HER-2/neu intracellular domain protein Plasmid vaccine | Clinical Trial Completed Successful

Data type

boolean

Alias
UMLS CUI [1,1]
C3146228
UMLS CUI [1,2]
C0597641
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1272703
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
male or female (male patients are not excluded)
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
zubrod performance status 0
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
unable to bear children (female patients)
Description

Gender Childbearing Potential Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
no cytoreductive chemotherapy within the past 30 days
Description

Chemotherapy Cytoreductive

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0864494
no cytotoxic treatment and/or systemic corticosteroids within the past month
Description

Cytotoxic therapy | CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C3653708
concurrent local radiotherapy or hormonal therapy allowed
Description

Therapeutic radiology procedure Local | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C0279025

Similar models

Eligibility Breast Cancer NCT00363012

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma TNM clinical staging
Item
diagnosis of stage iii/iv breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Chemotherapy Completed
Item
completed chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
trastuzumab | Herceptin
Item
receiving trastuzumab (herceptin®) monotherapy
boolean
C0728747 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
HER-2/neu intracellular domain protein Plasmid vaccine | Clinical Trial Completed Successful
Item
successful completion of her-2/neu (her2) intracellular domain (icd) plasmid-based vaccine trial (protocol 01-9773-d06: "a phase i safety and efficacy trial of a dna plasmid based vaccine encoding the her-2/neu intracellular domain in subjects with her-2/neu-overexpressing tumors") within the past 3 months
boolean
C3146228 (UMLS CUI [1,1])
C0597641 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
male or female (male patients are not excluded)
boolean
C0079399 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Zubrod Performance Status
Item
zubrod performance status 0
boolean
C3714786 (UMLS CUI [1])
Gender Childbearing Potential Lacking
Item
unable to bear children (female patients)
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
Chemotherapy Cytoreductive
Item
no cytoreductive chemotherapy within the past 30 days
boolean
C0392920 (UMLS CUI [1,1])
C0864494 (UMLS CUI [1,2])
Cytotoxic therapy | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
no cytotoxic treatment and/or systemic corticosteroids within the past month
boolean
C0677881 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Therapeutic radiology procedure Local | Hormone Therapy
Item
concurrent local radiotherapy or hormonal therapy allowed
boolean
C1522449 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])

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