ID

38385

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01514864

Trefwoorden

Versies (1)
  1. 15-10-19 15-10-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 oktober 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

Engels

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma Advanced

Datatype

boolean

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

Missense Mutation BRAF gene | Missense Mutation DDR2 gene

Datatype

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
Beschrijving

Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation

Datatype

boolean

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

Non-Small Cell Lung Carcinoma | DDR2 gene Mutation

Datatype

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
Beschrijving

Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation

Datatype

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
Beschrijving

Target Lesion Quantity

Datatype

boolean

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

Disease Progression | Status post Prior Therapy Quantity

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades

Datatype

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
Beschrijving

QTcF Prolongation | Congenital long QT syndrome

Datatype

boolean

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

Absolute neutrophil count

Datatype

boolean

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

Hemoglobin measurement

Datatype

boolean

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

Platelet Count measurement

Datatype

boolean

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

Serum calcium decreased

Datatype

boolean

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

Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient

Datatype

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)
Beschrijving

Serum creatinine raised

Datatype

boolean

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

Elevated total bilirubin

Datatype

boolean

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

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
Terug naar het begin van de pagina

Similar models

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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