ID

24788

Description

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

Lien

https://clinicaltrials.gov/show/NCT00478699

Mots-clés

Versions (1)
  1. 17/08/2017 17/08/2017 -
Téléchargé le

17 août 2017

DOI

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Licence

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

Anglais

Eligibility Non-small-cell Lung Cancer NCT00478699

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma

Type de données

boolean

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

Disease Complete excision

Type de données

boolean

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

Tumor tissue Available Molecular Analysis

Type de données

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.
Description

Lymph Node Involvement TNM clinical staging

Type de données

boolean

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

Age

Type de données

boolean

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

ECOG performance status

Type de données

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.
Description

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

Type de données

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.
Description

Operative Surgical Procedures Complete Recovery

Type de données

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.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Chemotherapy Study Disease | Therapeutic radiology procedure Study Disease

Type de données

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.
Description

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

Type de données

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.
Description

Communicable Disease | Heart Disease | Disease Serious

Type de données

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.
Description

Pregnancy | Breast Feeding

Type de données

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.
Description

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

Type de données

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.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non-small-cell Lung Cancer NCT00478699

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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