ID

41029

Beschreibung

A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00830245

Link

https://clinicaltrials.gov/show/NCT00830245

Stichworte

Versionen (1)
  1. 15.06.20 15.06.20 -
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See clinicaltrials.gov

Hochgeladen am

15. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leptomeningeal Carcinomatosis NCT00830245

Englisch

Eligibility Leptomeningeal Carcinomatosis NCT00830245

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age >18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or pathologically proven non-small cell lung cancer (nsclc)
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
3. leptomeningeal carcinomatosis confirmed by csf cytology
Beschreibung

Meningeal Carcinomatosis | Cerebrospinal Fluid Cytology

Datentyp

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2,1]
C0007806
UMLS CUI [2,2]
C1305671
4. a patients with egfr mutation (including exon 19 deletion, l858r)
Beschreibung

EGFR gene mutation | EGFR exon 19 deletion | EGFR L858R

Datentyp

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3274204
5. ecog performance status 0-3
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. expected life time more than at least 4 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. a patients who signed the informed consent prior to the participation in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
8. chemotherapy-naïve patient is eligible
Beschreibung

Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
9. previous egfr tki is allowed if this drug was not specifically used for cns metastases
Beschreibung

EGFR Tyrosine Kinase inhibitor | CNS metastases Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a pregnant or lactating patient
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. a patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
Beschreibung

Childbearing Potential Pregnancy Tests Lacking | Childbearing Potential Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0240802
3. a man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
Beschreibung

Females & males of reproductive potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
4. a patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
Beschreibung

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Early gastric cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0349530
5. a patient with active interstitial lung disease, except simple lymphangitic lung metastasis
Beschreibung

Lung Diseases, Interstitial | Exception Simple Lymphangitic metastasis to lung

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2062926
UMLS CUI [2,3]
C0205352
6. a patient with history of allergic reaction to gefitinib or erlotinib
Beschreibung

Allergic Reaction Gefitinib | Allergic Reaction Erlotinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1122962
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1135135
7. the following laboratory test results:
Beschreibung

Laboratory test result

Datentyp

boolean

Alias
UMLS CUI [1]
C0587081
number of absolute neutrophils counts (anc) < 1.0ⅹ109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
number of platelets < 50 ⅹ109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
ast, alt > 2.5 ⅹupper limit of normal
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
total bilirubin > 1.5 ⅹupper limit of normal
Beschreibung

Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
serum creatinine > 1.5 ⅹupper limit of normal
Beschreibung

Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
8. a patient with serious disease as followings
Beschreibung

Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
uncontrolled cardiac arrhythmia
Beschreibung

Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
history of myocardial infarction within 6 months prior to the initiation of study
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
neurological or psychiatric disorder including dementia or uncontrolled seizure
Beschreibung

Nervous system disorder | Mental disorders | Dementia | Seizures Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0497327
UMLS CUI [4,1]
C0036572
UMLS CUI [4,2]
C0205318
9. a patient who refused to sign the informed consent
Beschreibung

Informed Consent Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
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Ähnliche Modelle

Eligibility Leptomeningeal Carcinomatosis NCT00830245

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age >18
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
2. histologically or pathologically proven non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Meningeal Carcinomatosis | Cerebrospinal Fluid Cytology
Item
3. leptomeningeal carcinomatosis confirmed by csf cytology
boolean
C0220654 (UMLS CUI [1])
C0007806 (UMLS CUI [2,1])
C1305671 (UMLS CUI [2,2])
EGFR gene mutation | EGFR exon 19 deletion | EGFR L858R
Item
4. a patients with egfr mutation (including exon 19 deletion, l858r)
boolean
C3266992 (UMLS CUI [1])
C3889117 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
ECOG performance status
Item
5. ecog performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. expected life time more than at least 4 weeks
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
7. a patients who signed the informed consent prior to the participation in the study
boolean
C0021430 (UMLS CUI [1])
Chemotherapy Absent
Item
8. chemotherapy-naïve patient is eligible
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
EGFR Tyrosine Kinase inhibitor | CNS metastases Absent
Item
9. previous egfr tki is allowed if this drug was not specifically used for cns metastases
boolean
C1443775 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. a pregnant or lactating patient
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Pregnancy Tests Lacking | Childbearing Potential Pregnancy test positive
Item
2. a patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0240802 (UMLS CUI [2,2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
3. a man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Early gastric cancer
Item
4. a patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0349530 (UMLS CUI [4,3])
Lung Diseases, Interstitial | Exception Simple Lymphangitic metastasis to lung
Item
5. a patient with active interstitial lung disease, except simple lymphangitic lung metastasis
boolean
C0206062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2062926 (UMLS CUI [2,2])
C0205352 (UMLS CUI [2,3])
Allergic Reaction Gefitinib | Allergic Reaction Erlotinib
Item
6. a patient with history of allergic reaction to gefitinib or erlotinib
boolean
C1527304 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1135135 (UMLS CUI [2,2])
Laboratory test result
Item
7. the following laboratory test results:
boolean
C0587081 (UMLS CUI [1])
Absolute neutrophil count
Item
number of absolute neutrophils counts (anc) < 1.0ⅹ109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
number of platelets < 50 ⅹ109/l
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast, alt > 2.5 ⅹupper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Elevated total bilirubin
Item
total bilirubin > 1.5 ⅹupper limit of normal
boolean
C0741494 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine > 1.5 ⅹupper limit of normal
boolean
C0700225 (UMLS CUI [1])
Disease Serious
Item
8. a patient with serious disease as followings
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Cardiac Arrhythmia Uncontrolled
Item
uncontrolled cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Myocardial Infarction
Item
history of myocardial infarction within 6 months prior to the initiation of study
boolean
C0027051 (UMLS CUI [1])
Nervous system disorder | Mental disorders | Dementia | Seizures Uncontrolled
Item
neurological or psychiatric disorder including dementia or uncontrolled seizure
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0036572 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Informed Consent Refused
Item
9. a patient who refused to sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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