ID

31192

Beschreibung

Fluorine F18-EF5 and Fludeoxyglucose F18 Positron Emission Tomography in Assessing Hypoxia and Glycolysis in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01017133

Link

https://clinicaltrials.gov/show/NCT01017133

Stichworte

Versionen (1)
  1. 26.07.18 26.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Juli 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01017133

Englisch

Eligibility Non-small Cell Lung Cancer NCT01017133

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have a histologically confirmed nsclc or clinical and imaging evidence of a de novo mass that is likely to be a nsclc, stage i, ii, or iiia, for which surgery would be indicated for routine medical indications
Beschreibung

Non-Small Cell Lung Carcinoma | Mass de novo Imaging | Non-Small Cell Lung Carcinoma Probably TNM clinical staging | Indication Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0577559
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0750492
UMLS CUI [3,3]
C3258246
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0543467
ecog performance status between 0 and 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
wbc > 2,000/mm^3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
platelet count > 100,000/mm^3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
serum ast and alt
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
negative serum pregnancy test if a female of childbearing age
Beschreibung

Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5
Beschreibung

Allergic Reaction Flagyl | Allergic Reaction Metronidazole | Chemical Structure EF5 Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0699678
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0025872
UMLS CUI [3,1]
C0220807
UMLS CUI [3,2]
C1521807
UMLS CUI [3,3]
C2348205
uncontrolled intercurrent illness that would limit compliance with study requirements
Beschreibung

Comorbidity Uncontrolled | Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
pregnant women and women who are breastfeeding are excluded
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown
Beschreibung

Therapeutic radiology procedure Neoadjuvant prior to Biopsy | Chemotherapy Neoadjuvant prior to Biopsy | Therapeutic radiology procedure Neoadjuvant prior to Excision | Chemotherapy Neoadjuvant prior to Excision

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005558
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0005558
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0332152
UMLS CUI [3,4]
C0728940
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C0332152
UMLS CUI [4,4]
C0728940
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT01017133

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Mass de novo Imaging | Non-Small Cell Lung Carcinoma Probably TNM clinical staging | Indication Operative Surgical Procedures
Item
subjects must have a histologically confirmed nsclc or clinical and imaging evidence of a de novo mass that is likely to be a nsclc, stage i, ii, or iiia, for which surgery would be indicated for routine medical indications
boolean
C0007131 (UMLS CUI [1])
C0577559 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C0007131 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status between 0 and 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
boolean
C0021430 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc > 2,000/mm^3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum ast and alt
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
negative serum pregnancy test if a female of childbearing age
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Flagyl | Allergic Reaction Metronidazole | Chemical Structure EF5 Similar
Item
history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5
boolean
C1527304 (UMLS CUI [1,1])
C0699678 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0025872 (UMLS CUI [2,2])
C0220807 (UMLS CUI [3,1])
C1521807 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
Comorbidity Uncontrolled | Protocol Compliance Limited
Item
uncontrolled intercurrent illness that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant women and women who are breastfeeding are excluded
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic radiology procedure Neoadjuvant prior to Biopsy | Chemotherapy Neoadjuvant prior to Biopsy | Therapeutic radiology procedure Neoadjuvant prior to Excision | Chemotherapy Neoadjuvant prior to Excision
Item
subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown
boolean
C1522449 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0005558 (UMLS CUI [2,4])
C1522449 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0728940 (UMLS CUI [3,4])
C0392920 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
C0728940 (UMLS CUI [4,4])
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