ID

19752

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-01-17 26-01-17 -
Geüploaded op

26 januari 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven nsclc patients
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

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

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

Datatype

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
Beschrijving

Age

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Measurable Disease Linear

Datatype

boolean

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

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

Datatype

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
Beschrijving

FEV1 Preoperative

Datatype

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 ≥
Beschrijving

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

Datatype

boolean

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

Platelet Count measurement

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
superior sulcus tumor
Beschrijving

Pancoast Tumor

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Myocardial Infarction

Datatype

boolean

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

Postobstructive pneumonia | Communicable Disease Serious

Datatype

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.)
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datatype

boolean

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

Mental problem

Datatype

boolean

Alias
UMLS CUI [1]
C0848067
Terug naar het begin van de pagina

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00329472

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial