ID

19752

Beschreibung

Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00329472

Link

https://clinicaltrials.gov/show/NCT00329472

Stichworte

Versionen (1)
  1. 26.01.17 26.01.17 -
Hochgeladen am

26. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven nsclc patients
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
all patients must have:clinical stage ib, iia, iib and t3n1 by mediastinoscopy, chest ct and pet-ct
Beschreibung

TNM clinical staging Mediastinoscopy | TNM clinical staging X-Ray Computed Tomography Chest | TNM clinical staging PET/CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0025065
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C0040405
UMLS CUI [2,3]
C0817096
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C1699633
18 year of ages or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
uni-dimensionally measurable lesion by recist criteria
Beschreibung

Measurable Disease Linear

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
no prior chemotherapy or radiotherapy for nsclc
Beschreibung

Chemotherapy Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0007131
pre-operative fev1 ≥ 2.0 l evaluated within 28 days
Beschreibung

FEV1 Preoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0445204
adequate bone marrow function: hb > 9.0 g/dl, wbc ≥ 4,000/μl, platelet count ≥
Beschreibung

Bone Marrow function | Hemoglobin measurement | White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0023508
100,000/μl
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
adequate liver and renal function: total bilirubin < 2 x uln, ast/alt < 3 x uln, serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 60 ml/min
Beschreibung

Liver function | Renal function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
superior sulcus tumor
Beschreibung

Pancoast Tumor

Datentyp

boolean

Alias
UMLS CUI [1]
C0549471
prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
Beschreibung

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
uncontrolled systemic illness such as dm, chf, unstable angina or arrhythmia
Beschreibung

Systemic disease Uncontrolled | Diabetes Mellitus | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
recent myocardial infarction within 6 months
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
patients with post-obstructive pneumonia or serious infection
Beschreibung

Postobstructive pneumonia | Communicable Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0747690
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method.)
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
patients with psychological problem
Beschreibung

Mental problem

Datentyp

boolean

Alias
UMLS CUI [1]
C0848067
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically proven nsclc patients
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging Mediastinoscopy | TNM clinical staging X-Ray Computed Tomography Chest | TNM clinical staging PET/CT
Item
all patients must have:clinical stage ib, iia, iib and t3n1 by mediastinoscopy, chest ct and pet-ct
boolean
C3258246 (UMLS CUI [1,1])
C0025065 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0817096 (UMLS CUI [2,3])
C3258246 (UMLS CUI [3,1])
C1699633 (UMLS CUI [3,2])
Age
Item
18 year of ages or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Linear
Item
uni-dimensionally measurable lesion by recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
Chemotherapy Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure Non-Small Cell Lung Carcinoma
Item
no prior chemotherapy or radiotherapy for nsclc
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
FEV1 Preoperative
Item
pre-operative fev1 ≥ 2.0 l evaluated within 28 days
boolean
C0748133 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Bone Marrow function | Hemoglobin measurement | White Blood Cell Count procedure
Item
adequate bone marrow function: hb > 9.0 g/dl, wbc ≥ 4,000/μl, platelet count ≥
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Platelet Count measurement
Item
100,000/μl
boolean
C0032181 (UMLS CUI [1])
Liver function | Renal function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
adequate liver and renal function: total bilirubin < 2 x uln, ast/alt < 3 x uln, serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 60 ml/min
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pancoast Tumor
Item
superior sulcus tumor
boolean
C0549471 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated
Item
prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Systemic disease Uncontrolled | Diabetes Mellitus | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia
Item
uncontrolled systemic illness such as dm, chf, unstable angina or arrhythmia
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Myocardial Infarction
Item
recent myocardial infarction within 6 months
boolean
C0027051 (UMLS CUI [1])
Postobstructive pneumonia | Communicable Disease Serious
Item
patients with post-obstructive pneumonia or serious infection
boolean
C0747690 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Mental problem
Item
patients with psychological problem
boolean
C0848067 (UMLS CUI [1])
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