ID

30271

Descripción

Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00989690

Link

https://clinicaltrials.gov/show/NCT00989690

Palabras clave

  1. 26/5/18 26/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Lung Cancer NCT00989690

Eligibility Lung Cancer NCT00989690

Criteria
Descripción

Criteria

histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc)
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
advanced nsclc (stage iiib or iv)
Descripción

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced nsclc
Descripción

TNK1 Inhibitor | First line treatment Non-Small Cell Lung Carcinoma Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0387990
UMLS CUI [1,2]
C1999216
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205179
no clinical evidence of uncontrolled brain metastases
Descripción

Absence Metastatic malignant neoplasm to brain Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0205318
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
caucasian
Descripción

Caucasians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043157
ecog performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
absolute granulocyte count ≥ 1,500/mm^3
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm^3
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin ≤ 1.5 times upper limit of normal (uln) (≤ 2.5 times uln in patients with known liver metastases)
Descripción

Serum total bilirubin measurement | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0494165
alt or ast ≤ 3 times uln (≤ 5 times uln in patients with known liver metastases)
Descripción

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
creatinine clearance ≥ 50 ml/min
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
not pregnant or nursing
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
able to comply with planned study procedures
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
no multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
Descripción

Exclusion Criteria | Multiple diseases Severe compromise Safety | Heart failure | Kidney Failure | Peripheral Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1404410
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0036043
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0031117
no other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
Descripción

Exclusion Criteria | Cancer Other | Exception Basal cell carcinoma | Preneoplastic Condition Requirement Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C0282313
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0392920
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Descripción

ID.19

Tipo de datos

boolean

at least 3 weeks since prior surgery or radiotherapy
Descripción

Operative Surgical Procedures Previous | Prior radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134

Similar models

Eligibility Lung Cancer NCT00989690

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging
Item
advanced nsclc (stage iiib or iv)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
TNK1 Inhibitor | First line treatment Non-Small Cell Lung Carcinoma Advanced
Item
underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced nsclc
boolean
C0387990 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
Absence Metastatic malignant neoplasm to brain Uncontrolled
Item
no clinical evidence of uncontrolled brain metastases
boolean
C0332197 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Caucasians
Item
caucasian
boolean
C0043157 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute granulocyte count ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver
Item
bilirubin ≤ 1.5 times upper limit of normal (uln) (≤ 2.5 times uln in patients with known liver metastases)
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alt or ast ≤ 3 times uln (≤ 5 times uln in patients with known liver metastases)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Protocol Compliance
Item
able to comply with planned study procedures
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria | Multiple diseases Severe compromise Safety | Heart failure | Kidney Failure | Peripheral Neuropathy
Item
no multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
boolean
C0680251 (UMLS CUI [1])
C1404410 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0036043 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0031117 (UMLS CUI [5])
Exclusion Criteria | Cancer Other | Exception Basal cell carcinoma | Preneoplastic Condition Requirement Chemotherapy
Item
no other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
boolean
C0680251 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0282313 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.19
Item
see disease characteristics
boolean
Operative Surgical Procedures Previous | Prior radiation therapy
Item
at least 3 weeks since prior surgery or radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])

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