ID

24788

Beskrivning

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT); ODM derived from: https://clinicaltrials.gov/show/NCT00478699

Länk

https://clinicaltrials.gov/show/NCT00478699

Nyckelord

Versioner (1)
  1. 2017-08-17 2017-08-17 -
Uppladdad den

17 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small-cell Lung Cancer NCT00478699

Engelsk

Eligibility Non-small-cell Lung Cancer NCT00478699

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histological confirmation of non-small-cell lung carcinoma.
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
complete surgical resection of the disease.
Beskrivning

Disease Complete excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0015250
tumoral tissue available for molecular analysis.
Beskrivning

Tumor tissue Available Molecular Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C1513380
n1 (stage ii) or n2 (stage iiia) lymph node involvement in the study of the operative piece.
Beskrivning

Lymph Node Involvement TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C3258246
men or women age 18 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with a performance status of 2 or less according to the ecog classification.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients with the following laboratory results: anc < 1500/l, hb < 10 g/dl, platelets <100,000/l, bilirubin < 1.0 mg/dl, ast and alt < 1.5 upper limit of normality, creatinine clearance < 60 ml/min.
Beskrivning

Laboratory Results | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0373595
complete recovery from surgery within 6 weeks.
Beskrivning

Operative Surgical Procedures Complete Recovery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826210
patients who have given written informed consent before initiating any specific study screening procedure.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received previously chemotherapy or radiotherapy for the study disease.
Beskrivning

Chemotherapy Study Disease | Therapeutic radiology procedure Study Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C2603343
UMLS CUI [2,3]
C0012634
impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
Beskrivning

Chemotherapy | Compliance behavior Unsuccessful Due to Cultural reasons | Compliance behavior Unsuccessful Due to Geographic Factors

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3841422
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C1272705
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0017444
patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
Beskrivning

Communicable Disease | Heart Disease | Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0018799
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
women who are pregnant or in the period of lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
Beskrivning

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
patients under treatment with investigational agents.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non-small-cell Lung Cancer NCT00478699

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
patients with histological confirmation of non-small-cell lung carcinoma.
boolean
C0007131 (UMLS CUI [1])
Disease Complete excision
Item
complete surgical resection of the disease.
boolean
C0012634 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
Tumor tissue Available Molecular Analysis
Item
tumoral tissue available for molecular analysis.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1513380 (UMLS CUI [1,3])
Lymph Node Involvement TNM clinical staging
Item
n1 (stage ii) or n2 (stage iiia) lymph node involvement in the study of the operative piece.
boolean
C0806692 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
men or women age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients with a performance status of 2 or less according to the ecog classification.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement
Item
patients with the following laboratory results: anc < 1500/l, hb < 10 g/dl, platelets <100,000/l, bilirubin < 1.0 mg/dl, ast and alt < 1.5 upper limit of normality, creatinine clearance < 60 ml/min.
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Operative Surgical Procedures Complete Recovery
Item
complete recovery from surgery within 6 weeks.
boolean
C0543467 (UMLS CUI [1,1])
C2826210 (UMLS CUI [1,2])
Informed Consent
Item
patients who have given written informed consent before initiating any specific study screening procedure.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Study Disease | Therapeutic radiology procedure Study Disease
Item
patients who have received previously chemotherapy or radiotherapy for the study disease.
boolean
C0392920 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Chemotherapy | Compliance behavior Unsuccessful Due to Cultural reasons | Compliance behavior Unsuccessful Due to Geographic Factors
Item
impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
boolean
C0392920 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3841422 (UMLS CUI [2,4])
C1321605 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0017444 (UMLS CUI [3,4])
Communicable Disease | Heart Disease | Disease Serious
Item
patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
boolean
C0009450 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or in the period of lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Investigational New Drugs
Item
patients under treatment with investigational agents.
boolean
C0013230 (UMLS CUI [1])
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