ID

37225

Beskrivning

SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02500914

Länk

https://clinicaltrials.gov/show/NCT02500914

Nyckelord

  1. 2019-07-08 2019-07-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juli 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Small Cell Lung Cancer NCT02500914

Eligibility Small Cell Lung Cancer NCT02500914

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed sclc (either limited or extensive disease) or lcnec, that has relapsed from the most current treatment or was refractory to treatment
Beskrivning

Small cell carcinoma of lung | Small cell lung cancer limited stage | Small cell lung cancer extensive stage | Large cell neuroendocrine carcinoma of lung Relapse | Large cell neuroendocrine carcinoma of lung Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0149925
UMLS CUI [2]
C0278725
UMLS CUI [3]
C0278726
UMLS CUI [4,1]
C1334363
UMLS CUI [4,2]
C0277556
UMLS CUI [5,1]
C1334363
UMLS CUI [5,2]
C0205269
evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
Beskrivning

Progressive Disease | Chemotherapy Regimen Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
measurable disease as defined by recist
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological and organ function as confirmed by laboratory values
Beskrivning

Hematologic function | Organ function | Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
UMLS CUI [3]
C1254595
treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of sc-002
Beskrivning

Antineoplastic Agents | Investigational New Drugs | SC002

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0967624
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active central nervous system metastases
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
uncontrolled cardiac disease
Beskrivning

Heart Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
positive serology for hepatitis b or hepatitis c or known hiv infection
Beskrivning

Hepatitis B Serology positive | Hepatitis C Serology positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0242089
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0242089
UMLS CUI [3]
C0019699
presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results
Beskrivning

Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954

Similar models

Eligibility Small Cell Lung Cancer NCT02500914

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Small cell carcinoma of lung | Small cell lung cancer limited stage | Small cell lung cancer extensive stage | Large cell neuroendocrine carcinoma of lung Relapse | Large cell neuroendocrine carcinoma of lung Unresponsive to Treatment
Item
histologically or cytologically confirmed sclc (either limited or extensive disease) or lcnec, that has relapsed from the most current treatment or was refractory to treatment
boolean
C0149925 (UMLS CUI [1])
C0278725 (UMLS CUI [2])
C0278726 (UMLS CUI [3])
C1334363 (UMLS CUI [4,1])
C0277556 (UMLS CUI [4,2])
C1334363 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
Progressive Disease | Chemotherapy Regimen Quantity
Item
evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
boolean
C1335499 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease as defined by recist
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Organ function | Laboratory Results
Item
adequate hematological and organ function as confirmed by laboratory values
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
Antineoplastic Agents | Investigational New Drugs | SC002
Item
treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of sc-002
boolean
C0003392 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0967624 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
active central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Heart Disease Uncontrolled
Item
uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hepatitis B Serology positive | Hepatitis C Serology positive | HIV Seropositivity
Item
positive serology for hepatitis b or hepatitis c or known hiv infection
boolean
C0019163 (UMLS CUI [1,1])
C0242089 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0242089 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research results
Item
presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])

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