ID

31203

Beskrivning

FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01170923

Länk

https://clinicaltrials.gov/show/NCT01170923

Nyckelord

Versioner (1)
  1. 2018-07-28 2018-07-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01170923

Engelsk

Eligibility Non-small Cell Lung Cancer NCT01170923

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed non-small cell carcinoma.
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
2. stage iiib (wet) or iv advanced nsclc.
Beskrivning

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
3. no evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
Beskrivning

Malignant Neoplasms Previous Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
4. measurable disease by recist criteria.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
5. adequate organ function as follows.
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
seum ast/alt < 2.5 x upper normal limit (unl) (if hepatic metastasis < 5 x unl)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
total bilirubin < 1.5 x unl
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine < 1.5 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
absolute neutrophil count > 1500/ul
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet > 100,000/ul
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin > 9.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
6. ecog performance status 0-1 7 age > 18
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. if previously treated with major surgery, it should be over at least 4 weeks. and if previously treated with radiotherapy, it should be over at least 2 weeks.
Beskrivning

Major surgery | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
9. written consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous chemotherapy.
Beskrivning

Prior Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
2. symptomatic brain metastasis.
Beskrivning

Metastatic malignant neoplasm to brain Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
3. concurrent severe medical illness.
Beskrivning

Illness Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
4. pregnancy and lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. if there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
Beskrivning

Finding Chemotherapy At risk | Finding Preventing Analysis Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0936012
UMLS CUI [2,4]
C0683954
uncontrolled diabetes mellitus.
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01170923

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. histologically confirmed non-small cell carcinoma.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging
Item
2. stage iiib (wet) or iv advanced nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Malignant Neoplasms Previous Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
3. no evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Measurable Disease
Item
4. measurable disease by recist criteria.
boolean
C1513041 (UMLS CUI [1])
Organ function
Item
5. adequate organ function as follows.
boolean
C0678852 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
seum ast/alt < 2.5 x upper normal limit (unl) (if hepatic metastasis < 5 x unl)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x unl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 1500/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet > 100,000/ul
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin > 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status 0-1 7 age > 18
boolean
C1520224 (UMLS CUI [1])
Major surgery | Therapeutic radiology procedure
Item
8. if previously treated with major surgery, it should be over at least 4 weeks. and if previously treated with radiotherapy, it should be over at least 2 weeks.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Informed Consent
Item
9. written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy
Item
1. previous chemotherapy.
boolean
C1514457 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic
Item
2. symptomatic brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Illness Severe
Item
3. concurrent severe medical illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
4. pregnancy and lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Finding Chemotherapy At risk | Finding Preventing Analysis Research results
Item
5. if there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
boolean
C0243095 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0936012 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Diabetic - poor control
Item
uncontrolled diabetes mellitus.
boolean
C0421258 (UMLS CUI [1])
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