ID

36634

Beskrivning

Neoadjuvant Anti-PD-1, Nivolumab in Resectable NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02259621

Länk

https://clinicaltrials.gov/show/NCT02259621

Nyckelord

Versioner (1)
  1. 2019-05-27 2019-05-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02259621

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT02259621

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven non-small-cell lung cancer (core biopsy required).
Beskrivning

Non-Small Cell Lung Carcinoma | Core biopsy Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C1514873
squamous or non-squamous histology (note - at least 4 squamous patients will be included in the total enrollment of 16 patients)
Beskrivning

Squamous non-small cell lung cancer | Non-squamous non-small cell lung cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C4509816
UMLS CUI [2]
C4324656
diagnostic core biopsy specimens must be reviewed by a faculty pathologist at skccc or mskcc
Beskrivning

Specimen obtained by core needle biopsy Reviewed By Pathologist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1960700
UMLS CUI [1,2]
C1709941
UMLS CUI [1,3]
C0334866
either a formalin fixed paraffin block or a minimum of ten 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling). this can be obtained from archived tissues, or from a new biopsy if needed.
Beskrivning

Formalin-fixed paraffin-embedded tissue specimen | Tumor tissue sample Micron Tissue section Quantity | Biomarker Evaluation

Datatyp

boolean

Alias
UMLS CUI [1]
C2711483
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0439201
UMLS CUI [2,3]
C2316368
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0005516
UMLS CUI [3,2]
C1261322
stage - high risk nsclc with resection option for potential cure, as assessed by a faculty surgeon at skccc or mskcc. this includes clinical stage ib (primary tumor must measure
Beskrivning

Non-Small Cell Lung Carcinoma High risk | Excision Option | Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C4319571
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C1518601
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3258246
≥4cm in diameter on ct imaging), ii and iiia (n1 disease only) (see appendix a):
Beskrivning

Primary tumor Diameter CT scan | Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
t1a, t1b, t2a, n1, m0
Beskrivning

Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
t2a (≥4cm diameter), n0, m0
Beskrivning

Disease TNM clinical staging | Diameter size

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0456389
t2b, n0 or 1, m0
Beskrivning

Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
t3, n0, m0
Beskrivning

Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
t3, n1 (deemed suitable for primary resection by treating surgeon)
Beskrivning

Disease TNM clinical staging | Appropriateness Excision Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0814634
UMLS CUI [2,2]
C0728940
UMLS CUI [2,3]
C0205225
ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
stable lab values
Beskrivning

Laboratory Results Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205360
adequate cardiac function as defined by: no evidence of pr prolongation or av block on baseline electrocardiogram (ecg).
Beskrivning

Cardiac function | Prolonged PR interval Absent ECG | Atrioventricular Block Absent ECG

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0600125
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1623258
UMLS CUI [3,1]
C0004245
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1623258
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
Beskrivning

Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunosuppressive Agents | Inflammatory Bowel Disease | Exception Vitiligo | Exception Childhood asthma resolved | Exception Atopy resolved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2825233
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [3]
C0021390
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0042900
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0264408
UMLS CUI [5,3]
C1514893
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0392707
UMLS CUI [6,3]
C1514893
ongoing requirement for systemic corticosteroids. however, inhalational steroids are allowed.
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE | Inhaled steroids allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0683607
subjects who require or may require pneumonectomy, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
Beskrivning

Pneumonectomy | Excision Curative Primary tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C0032284
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C0677930
subjects with brain metastasis are excluded from this study and all patients should have brain imaging (either mri brain or ct brain with contrast) prior to enrollment.
Beskrivning

Metastatic malignant neoplasm to brain | Imaging of brain Required | MRI brain | CT scan of brain Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0203860
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C0412675
UMLS CUI [4,1]
C0412585
UMLS CUI [4,2]
C0009924
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02259621

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Core biopsy Required
Item
histologically proven non-small-cell lung cancer (core biopsy required).
boolean
C0007131 (UMLS CUI [1])
C1318309 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Squamous non-small cell lung cancer | Non-squamous non-small cell lung cancer
Item
squamous or non-squamous histology (note - at least 4 squamous patients will be included in the total enrollment of 16 patients)
boolean
C4509816 (UMLS CUI [1])
C4324656 (UMLS CUI [2])
Specimen obtained by core needle biopsy Reviewed By Pathologist
Item
diagnostic core biopsy specimens must be reviewed by a faculty pathologist at skccc or mskcc
boolean
C1960700 (UMLS CUI [1,1])
C1709941 (UMLS CUI [1,2])
C0334866 (UMLS CUI [1,3])
Formalin-fixed paraffin-embedded tissue specimen | Tumor tissue sample Micron Tissue section Quantity | Biomarker Evaluation
Item
either a formalin fixed paraffin block or a minimum of ten 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling). this can be obtained from archived tissues, or from a new biopsy if needed.
boolean
C2711483 (UMLS CUI [1])
C0475358 (UMLS CUI [2,1])
C0439201 (UMLS CUI [2,2])
C2316368 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0005516 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
Non-Small Cell Lung Carcinoma High risk | Excision Option | Disease TNM clinical staging
Item
stage - high risk nsclc with resection option for potential cure, as assessed by a faculty surgeon at skccc or mskcc. this includes clinical stage ib (primary tumor must measure
boolean
C0007131 (UMLS CUI [1,1])
C4319571 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2,1])
C1518601 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Primary tumor Diameter CT scan | Disease TNM clinical staging
Item
≥4cm in diameter on ct imaging), ii and iiia (n1 disease only) (see appendix a):
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Disease TNM clinical staging
Item
t1a, t1b, t2a, n1, m0
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease TNM clinical staging | Diameter size
Item
t2a (≥4cm diameter), n0, m0
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Disease TNM clinical staging
Item
t2b, n0 or 1, m0
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
t3, n0, m0
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease TNM clinical staging | Appropriateness Excision Primary
Item
t3, n1 (deemed suitable for primary resection by treating surgeon)
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0814634 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Stable
Item
stable lab values
boolean
C1254595 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Cardiac function | Prolonged PR interval Absent ECG | Atrioventricular Block Absent ECG
Item
adequate cardiac function as defined by: no evidence of pr prolongation or av block on baseline electrocardiogram (ecg).
boolean
C0232164 (UMLS CUI [1])
C0600125 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1623258 (UMLS CUI [2,3])
C0004245 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunosuppressive Agents | Inflammatory Bowel Disease | Exception Vitiligo | Exception Childhood asthma resolved | Exception Atopy resolved
Item
any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0021390 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0042900 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0264408 (UMLS CUI [5,2])
C1514893 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0392707 (UMLS CUI [6,2])
C1514893 (UMLS CUI [6,3])
CORTICOSTEROIDS FOR SYSTEMIC USE | Inhaled steroids allowed
Item
ongoing requirement for systemic corticosteroids. however, inhalational steroids are allowed.
boolean
C3653708 (UMLS CUI [1])
C2065041 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Pneumonectomy | Excision Curative Primary tumor
Item
subjects who require or may require pneumonectomy, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
boolean
C0032284 (UMLS CUI [1])
C0728940 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C0677930 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain | Imaging of brain Required | MRI brain | CT scan of brain Contrast Media
Item
subjects with brain metastasis are excluded from this study and all patients should have brain imaging (either mri brain or ct brain with contrast) prior to enrollment.
boolean
C0220650 (UMLS CUI [1])
C0203860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0412675 (UMLS CUI [3])
C0412585 (UMLS CUI [4,1])
C0009924 (UMLS CUI [4,2])
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