ID

36587

Beschrijving

TAURAS - T790 AURA ScreenFailure SOC Registry Study; ODM derived from: https://clinicaltrials.gov/show/NCT02405247

Link

https://clinicaltrials.gov/show/NCT02405247

Trefwoorden

Versies (1)
  1. 23-05-19 23-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT02405247

Engels

Eligibility Non Small Cell Lung Cancer NCT02405247

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated/allowed by local regulations
Beschrijving

Informed Consent | Informed Consent Patient's next of kin

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0421492
2. aged at least 18 years. patients from japan aged at least 20 years
Beschrijving

Age | Japanese

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1556094
3. patients who have been considered ineligible for entry into the azd9291 aura3 registration trial as a result of their tumour not harbouring the t790m mutation, according to the cobas egfr test of a biopsy taken following the latest line of therapy, at a central testing lab participating in the d5160c00003 (aura3) study.
Beschrijving

Neoplasm EGFR T790M Mutation Negative | Biopsy EGFR gene mutation Test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C4329762
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C3266992
UMLS CUI [2,3]
C0039593
4. patients who have undertaken or plan to undertake 2nd-line therapy after screen failure for the aura3 study.
Beschrijving

Second line treatment | Second line treatment Planned

Datatype

boolean

Alias
UMLS CUI [1]
C1710038
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C1301732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with any of the following:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
prior treatment with more than one line of systemic treatment for advanced disease prior to failing screening assessments for aura3.
Beschrijving

Prior Therapy | Systemic therapy Quantity Advanced disease

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0679246
major surgery (excluding placement of vascular access) within 4 weeks prior to failing screening assessments for aura3.
Beschrijving

Major surgery | Exception Vascular Access Device Placement

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1519955
palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to failing screening assessments for aura3..
Beschrijving

Palliative course of radiotherapy Radiation Field Limited | Exception Therapeutic radiology procedure Bone Marrow Percentage | Exception Radiation Field Wide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0439165
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1882536
UMLS CUI [3,3]
C0332464
2. spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to failing screening assessments for aura3..
Beschrijving

Compression of spinal cord | Metastatic malignant neoplasm to brain | Exception Asymptomatic Disease | Exception Stable status | Exception Steroids Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2936329
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038317
UMLS CUI [5,3]
C0332197
3. involvement in the planning and conduct of the study (applies to astrazeneca staff or staff at the study site).
Beschrijving

Involvement with Clinical Trial Planning | Involvement with Completion of clinical trial | Staff Study Site

Datatype

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C2732579
UMLS CUI [3,1]
C0851286
UMLS CUI [3,2]
C2825164
4. judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Beschrijving

Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
5. patients who are known to be entering an interventional clinical study (blinded, randomized or open label clinical study) at the time of the enrolment into this study. however, inclusion in this study does not preclude participation in any other clinical study after enrolment. patients who participate in clinical studies after enrolment into this study will be followed up to the extent possible as permitted by the sponsor of that clinical study.
Beschrijving

Study Subject Participation Status | Interventional Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
6. patients with an invalid or unsuccessful t790m mutation test result during screening for aura3.
Beschrijving

EGFR T790M Mutation Test Result Invalid | EGFR T790M Mutation Test Result Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0456984
UMLS CUI [1,4]
C3245471
UMLS CUI [2,1]
C3274192
UMLS CUI [2,2]
C0026882
UMLS CUI [2,3]
C0456984
UMLS CUI [2,4]
C1272705
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Similar models

Eligibility Non Small Cell Lung Cancer NCT02405247

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Patient's next of kin
Item
1. provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated/allowed by local regulations
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0421492 (UMLS CUI [2,2])
Age | Japanese
Item
2. aged at least 18 years. patients from japan aged at least 20 years
boolean
C0001779 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Neoplasm EGFR T790M Mutation Negative | Biopsy EGFR gene mutation Test
Item
3. patients who have been considered ineligible for entry into the azd9291 aura3 registration trial as a result of their tumour not harbouring the t790m mutation, according to the cobas egfr test of a biopsy taken following the latest line of therapy, at a central testing lab participating in the d5160c00003 (aura3) study.
boolean
C0027651 (UMLS CUI [1,1])
C4329762 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C3266992 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
Second line treatment | Second line treatment Planned
Item
4. patients who have undertaken or plan to undertake 2nd-line therapy after screen failure for the aura3 study.
boolean
C1710038 (UMLS CUI [1])
C1710038 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure
Item
1. treatment with any of the following:
boolean
C0087111 (UMLS CUI [1])
Prior Therapy | Systemic therapy Quantity Advanced disease
Item
prior treatment with more than one line of systemic treatment for advanced disease prior to failing screening assessments for aura3.
boolean
C1514463 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
Major surgery | Exception Vascular Access Device Placement
Item
major surgery (excluding placement of vascular access) within 4 weeks prior to failing screening assessments for aura3.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1519955 (UMLS CUI [2,2])
Palliative course of radiotherapy Radiation Field Limited | Exception Therapeutic radiology procedure Bone Marrow Percentage | Exception Radiation Field Wide
Item
palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to failing screening assessments for aura3..
boolean
C0475092 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1882536 (UMLS CUI [3,2])
C0332464 (UMLS CUI [3,3])
Compression of spinal cord | Metastatic malignant neoplasm to brain | Exception Asymptomatic Disease | Exception Stable status | Exception Steroids Absent
Item
2. spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to failing screening assessments for aura3..
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2936329 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Involvement with Clinical Trial Planning | Involvement with Completion of clinical trial | Staff Study Site
Item
3. involvement in the planning and conduct of the study (applies to astrazeneca staff or staff at the study site).
boolean
C1314939 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
C0851286 (UMLS CUI [3,1])
C2825164 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely
Item
4. judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Study Subject Participation Status | Interventional Study
Item
5. patients who are known to be entering an interventional clinical study (blinded, randomized or open label clinical study) at the time of the enrolment into this study. however, inclusion in this study does not preclude participation in any other clinical study after enrolment. patients who participate in clinical studies after enrolment into this study will be followed up to the extent possible as permitted by the sponsor of that clinical study.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
EGFR T790M Mutation Test Result Invalid | EGFR T790M Mutation Test Result Unsuccessful
Item
6. patients with an invalid or unsuccessful t790m mutation test result during screening for aura3.
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C3245471 (UMLS CUI [1,4])
C3274192 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
C0456984 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
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