ID

13960

Description

Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02204059

Link

https://clinicaltrials.gov/show/NCT02204059

Keywords

  1. 3/20/16 3/20/16 -
Uploaded on

March 20, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Carcinoma, Non-Small-Cell Lung NCT02204059

Eligibility Carcinoma, Non-Small-Cell Lung NCT02204059

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histological or cytological confirmation of non small cell lung cancer (nsclc) stage i, ii or iiia according to the staging system of the american joint committee on cancer (ajcc)
Description

Staging

Data type

boolean

Alias
UMLS CUI [1]
C0280217
patients destined for resection of the tumour
Description

Tumour resection

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0006826
patients over 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients younger than 80 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who had given 'written informed consent'
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients with a life expectancy of at least 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients with a good performance status: karnofsky > 60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on electrocardiogram (ecg) or unstable angina pectoris
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pre-menopausal women (last menstruation <= 1 year prior to study start)
Description

Pre-menopausal status

Data type

boolean

Alias
UMLS CUI [1]
C0279752
not surgically sterile (hysterectomy, tubal ligation) and
Description

Hysterectomy, tubal ligation

Data type

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2]
C0520483
not practicing acceptable means of birth control, (or not planned to be continued throughout the study). acceptable methods of birth control include oral, implantable or injectable contraceptives
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
women with a positive serum pregnancy test at baseline
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
white blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. details of prior chemotherapy and radiotherapy had to be known.
Description

Laboratory parameters and prior therapy

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1522449
hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02204059

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Staging
Item
patients must have histological or cytological confirmation of non small cell lung cancer (nsclc) stage i, ii or iiia according to the staging system of the american joint committee on cancer (ajcc)
boolean
C0280217 (UMLS CUI [1])
Tumour resection
Item
patients destined for resection of the tumour
boolean
C0728940 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Age
Item
patients over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Age
Item
patients younger than 80 years of age
boolean
C0001779 (UMLS CUI [1])
Written informed consent
Item
patients who had given 'written informed consent'
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
patients with a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status
Item
patients with a good performance status: karnofsky > 60
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity
Item
life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on electrocardiogram (ecg) or unstable angina pectoris
boolean
C0009488 (UMLS CUI [1])
Pre-menopausal status
Item
pre-menopausal women (last menstruation <= 1 year prior to study start)
boolean
C0279752 (UMLS CUI [1])
Hysterectomy, tubal ligation
Item
not surgically sterile (hysterectomy, tubal ligation) and
boolean
C0020699 (UMLS CUI [1])
C0520483 (UMLS CUI [2])
Contraceptive methods
Item
not practicing acceptable means of birth control, (or not planned to be continued throughout the study). acceptable methods of birth control include oral, implantable or injectable contraceptives
boolean
C0700589 (UMLS CUI [1])
Pregnancy
Item
women with a positive serum pregnancy test at baseline
boolean
C0032961 (UMLS CUI [1])
Laboratory parameters and prior therapy
Item
white blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. details of prior chemotherapy and radiotherapy had to be known.
boolean
C0023508 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Comorbidity
Item
hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
boolean
C0009488 (UMLS CUI [1])

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