ID

16454

Beschrijving

A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00152477

Link

https://clinicaltrials.gov/show/NCT00152477

Trefwoorden

  1. 17-07-16 17-07-16 -
  2. 21-07-16 21-07-16 - Julian Varghese
Geüploaded op

17 juli 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Carcinoma NCT00152477

Eligibility Carcinoma NCT00152477

  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00152477
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects with stage iiib (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), stage iv, or recurrent non-squamous, non-small-cell lung carcinoma.
Beschrijving

Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
the subject must be aged 18 years or above.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the subject must have ecog performance status of 0 or 1 and a life expectancy of at least three months.
Beschrijving

ECOG and life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
subjects will have measurable disease.
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
the subject must be able to understand the information provided to them and to give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the investigator.
Beschrijving

Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
male subjects must be using a method of contraception judged reliable by the investigator.
Beschrijving

Contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with squamous cell lung carcinoma.
Beschrijving

Squamous cell lung carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0149782
subjects with lung lesions located centrally in the chest that involve major blood vessels.
Beschrijving

lung lesions located centrally in the chest

Datatype

boolean

Alias
UMLS CUI [1,1]
C0577916
UMLS CUI [1,2]
C0929406
concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
Beschrijving

Malignancies

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of screening visit, tuberculosis or epilepsy.
Beschrijving

additional major chronic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
subjects known to be infected with hepatitis b or c virus or hiv 1 or 2.
Beschrijving

hepatitis b or c virus or hiv 1 or 2

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
Beschrijving

Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450

Similar models

Eligibility Carcinoma NCT00152477

  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00152477
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Lung Carcinoma
Item
male and female subjects with stage iiib (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), stage iv, or recurrent non-squamous, non-small-cell lung carcinoma.
boolean
C0007131 (UMLS CUI [1])
Age
Item
the subject must be aged 18 years or above.
boolean
C0001779 (UMLS CUI [1])
ECOG and life expectancy
Item
the subject must have ecog performance status of 0 or 1 and a life expectancy of at least three months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Measurable Disease
Item
subjects will have measurable disease.
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
the subject must be able to understand the information provided to them and to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential
Item
female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the investigator.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Contraception
Item
male subjects must be using a method of contraception judged reliable by the investigator.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Squamous cell lung carcinoma
Item
subjects with squamous cell lung carcinoma.
boolean
C0149782 (UMLS CUI [1])
lung lesions located centrally in the chest
Item
subjects with lung lesions located centrally in the chest that involve major blood vessels.
boolean
C0577916 (UMLS CUI [1,1])
C0929406 (UMLS CUI [1,2])
Malignancies
Item
concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
boolean
C0006826 (UMLS CUI [1])
additional major chronic disease
Item
presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of screening visit, tuberculosis or epilepsy.
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
hepatitis b or c virus or hiv 1 or 2
Item
subjects known to be infected with hepatitis b or c virus or hiv 1 or 2.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Infection
Item
any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
boolean
C0009450 (UMLS CUI [1])

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