ID

38385

Beskrivning

Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT01514864

Länk

https://clinicaltrials.gov/show/NCT01514864

Nyckelord

Versioner (1)
  1. 2019-10-15 2019-10-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 oktober 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

Engelsk

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of advanced malignancy, non-small cell lung cancer (nsclc) only during stage 1 of accrual
Beskrivning

Non-Small Cell Lung Carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
non-synonymous mutation of b-raf or ddr2, defined as follows:
Beskrivning

Missense Mutation BRAF gene | Missense Mutation DDR2 gene

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599155
UMLS CUI [1,2]
C0812241
UMLS CUI [2,1]
C0599155
UMLS CUI [2,2]
C1333207
nsclc with inactivating b-raf mutation
Beskrivning

Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0598496
UMLS CUI [2,2]
C1511021
nsclc with ddr2 mutation
Beskrivning

Non-Small Cell Lung Carcinoma | DDR2 gene Mutation

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C1333207
UMLS CUI [2,2]
C0596611
malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation which is not functionally characterized
Beskrivning

Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1333207
UMLS CUI [2,2]
C0596611
UMLS CUI [3,1]
C0598496
UMLS CUI [3,2]
C1511021
at least one target lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria on baseline staging evaluation
Beskrivning

Target Lesion Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
disease progression after ≥ 1 prior treatment regimen
Beskrivning

Disease Progression | Status post Prior Therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C1265611
exception: subjects with nsclc of squamous type and ddr2 mutation may be enrolled in first line, no prior treatment is required
Beskrivning

Exception First line treatment Squamous non-small cell lung cancer | Exception First line treatment DDR2 gene Mutation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C4509816
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C1333207
UMLS CUI [2,4]
C0596611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pleural or pericardial effusion grade > 1
Beskrivning

Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C1516728
qtcf > 470 msec (grade ≥ 2) or diagnosed congenital long qt syndrome
Beskrivning

QTcF Prolongation | Congenital long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C3828431
UMLS CUI [2]
C1141890
absolute granulocyte count < 1,500/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin < 10 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
platelet count < 75,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
serum calcium < institutional lower limit of normal (lln)
Beskrivning

Serum calcium decreased

Datatyp

boolean

Alias
UMLS CUI [1]
C0595882
hypokalemia, hypophosphatemia or hypomagnesemia grade > 1, despite supplementation
Beskrivning

Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020621
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0085682
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0151723
UMLS CUI [3,2]
C0441800
UMLS CUI [4,1]
C0242297
UMLS CUI [4,2]
C0231185
creatinine > 3 x institutional upper limit of normal (uln)
Beskrivning

Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
total bilirubin > 1.5 x uln
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
alanine transaminase (alt) > 3 x uln
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
Tillbaka till toppen

Similar models

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced
Item
diagnosis of advanced malignancy, non-small cell lung cancer (nsclc) only during stage 1 of accrual
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Missense Mutation BRAF gene | Missense Mutation DDR2 gene
Item
non-synonymous mutation of b-raf or ddr2, defined as follows:
boolean
C0599155 (UMLS CUI [1,1])
C0812241 (UMLS CUI [1,2])
C0599155 (UMLS CUI [2,1])
C1333207 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation
Item
nsclc with inactivating b-raf mutation
boolean
C0007131 (UMLS CUI [1])
C0598496 (UMLS CUI [2,1])
C1511021 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | DDR2 gene Mutation
Item
nsclc with ddr2 mutation
boolean
C0007131 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation
Item
malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation which is not functionally characterized
boolean
C1707251 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
C0598496 (UMLS CUI [3,1])
C1511021 (UMLS CUI [3,2])
Target Lesion Quantity
Item
at least one target lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria on baseline staging evaluation
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Disease Progression | Status post Prior Therapy Quantity
Item
disease progression after ≥ 1 prior treatment regimen
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Exception First line treatment Squamous non-small cell lung cancer | Exception First line treatment DDR2 gene Mutation
Item
exception: subjects with nsclc of squamous type and ddr2 mutation may be enrolled in first line, no prior treatment is required
boolean
C1705847 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C4509816 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1333207 (UMLS CUI [2,3])
C0596611 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades
Item
pleural or pericardial effusion grade > 1
boolean
C0032227 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031039 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
QTcF Prolongation | Congenital long QT syndrome
Item
qtcf > 470 msec (grade ≥ 2) or diagnosed congenital long qt syndrome
boolean
C3828431 (UMLS CUI [1])
C1141890 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute granulocyte count < 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum calcium decreased
Item
serum calcium < institutional lower limit of normal (lln)
boolean
C0595882 (UMLS CUI [1])
Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient
Item
hypokalemia, hypophosphatemia or hypomagnesemia grade > 1, despite supplementation
boolean
C0020621 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0085682 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0151723 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0242297 (UMLS CUI [4,1])
C0231185 (UMLS CUI [4,2])
Serum creatinine raised
Item
creatinine > 3 x institutional upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine transaminase (alt) > 3 x uln
boolean
C0151905 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial