ID

15634

Beskrivning

T790M Mutation Positive 2nd Line STandard of cAre Registry; ODM derived from: https://clinicaltrials.gov/show/NCT02368990

Länk

https://clinicaltrials.gov/show/NCT02368990

Nyckelord

Versioner (1)
  1. 2016-06-06 2016-06-06 -
Uppladdad den

6 juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT02368990

Engelsk

Eligibility Non Small Cell Lung Cancer NCT02368990

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed and dated written informed consent prior to any study specific procedure.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients with histologically- or cytologically-documented nsclc who present with stage iiib/ stage iv disease.
Beskrivning

Non-Small Cell Lung Carcinoma | Non-small cell lung cancer stage IIIB | Non-small cell lung cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0278984
UMLS CUI [3]
C0278987
evidence of radiological disease progression following 1st line treatment for advanced/metastatic nsclc with an approved egfr-targeted tki monotherapy without any additional concurrent nsclc treatment. chemotherapy received in the adjuvant setting is permitted.
Beskrivning

First line treatment Non-small cell lung cancer metastatic | First line treatment Non-Small Cell Lung Carcinoma Advanced phase | Disease Progression Radiological tumor control | Epidermal growth factor receptor inhibitor Therapeutic procedure | Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0278987
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205179
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0475190
UMLS CUI [4,1]
C1443775
UMLS CUI [4,2]
C0087111
UMLS CUI [5]
C0392920
patients prescribed platinum based doublet chemotherapy (pemetrexed +
Beskrivning

Chemotherapy Platinum-Based | Pemetrexed-Cisplatin Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C1514162
UMLS CUI [2]
C1882310
cisplatin/carboplatin) for 2nd line treatment of nsclc. treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. patient must be enrolled into the study within two cycles of beginning treatment. treatment must be given in accordance with local prescribing information.
Beskrivning

Chemotherapy pemetrexed Carboplatin | Second line treatment Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0210657
UMLS CUI [1,3]
C0079083
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0007131
confirmation prior to enrolment into the study that the tumour harbours the following egfr mutations known to be associated with egfr-targeted tki sensitivity: ex19del, l858r, l861q, and g719x.
Beskrivning

Neoplasms | EGFR-TKI Sensitizing Mutation | EGFR NP_005219.2:p.L858R | EGFR NP_005219.2:p.L861Q | EGFR NP_005219.2:p.G719X

Datatyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2]
C3273083
UMLS CUI [3]
C3274204
UMLS CUI [4]
C3274186
UMLS CUI [5]
C3830332
patients must have had confirmation that tumour is t790m mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved egfr-targeted tki.
Beskrivning

Neoplasms | EGFR NP_005219.2:p.T790M Gene mutation identification test positive | Disease Progression | First line treatment EGFR-TKI Sensitizing Mutation

Datatyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C3274192
UMLS CUI [2,2]
C1504360
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C3273083
who performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Beskrivning

WHO performance status scale | Deterioration Absent | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2,1]
C0868945
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any of the following:
Beskrivning

Therapeutic procedure Following

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332282
prior treatment with more than one line of treatment for advanced nsclc.
Beskrivning

Prior Therapy Non-Small Cell Lung Carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
Beskrivning

major surgery | Vascular Access Device Placement

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [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 enrolment.
Beskrivning

Palliative course of radiotherapy | Radiation Field | Bone Marrow

Datatyp

boolean

Alias
UMLS CUI [1]
C0475092
UMLS CUI [2]
C1882536
UMLS CUI [3]
C0005953
spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0231221
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C0205360
UMLS CUI [5]
C0038317
patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. 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 to the extent possible as permitted by the sponsor of that clinical study.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
involvement in the planning and conduct of the study (applies to astrazeneca staff or staff at the site).
Beskrivning

Involvement with Study Staff

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0851286
judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
Beskrivning

Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Non Small Cell Lung Cancer NCT02368990

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
provision of signed and dated written informed consent prior to any study specific procedure.
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | Non-small cell lung cancer stage IIIB | Non-small cell lung cancer metastatic
Item
patients with histologically- or cytologically-documented nsclc who present with stage iiib/ stage iv disease.
boolean
C0007131 (UMLS CUI [1])
C0278984 (UMLS CUI [2])
C0278987 (UMLS CUI [3])
First line treatment Non-small cell lung cancer metastatic | First line treatment Non-Small Cell Lung Carcinoma Advanced phase | Disease Progression Radiological tumor control | Epidermal growth factor receptor inhibitor Therapeutic procedure | Chemotherapy Regimen
Item
evidence of radiological disease progression following 1st line treatment for advanced/metastatic nsclc with an approved egfr-targeted tki monotherapy without any additional concurrent nsclc treatment. chemotherapy received in the adjuvant setting is permitted.
boolean
C1708063 (UMLS CUI [1,1])
C0278987 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0475190 (UMLS CUI [3,2])
C1443775 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5])
Chemotherapy Platinum-Based | Pemetrexed-Cisplatin Regimen
Item
patients prescribed platinum based doublet chemotherapy (pemetrexed +
boolean
C3665472 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1882310 (UMLS CUI [2])
Chemotherapy pemetrexed Carboplatin | Second line treatment Non-Small Cell Lung Carcinoma
Item
cisplatin/carboplatin) for 2nd line treatment of nsclc. treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. patient must be enrolled into the study within two cycles of beginning treatment. treatment must be given in accordance with local prescribing information.
boolean
C3665472 (UMLS CUI [1,1])
C0210657 (UMLS CUI [1,2])
C0079083 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Neoplasms | EGFR-TKI Sensitizing Mutation | EGFR NP_005219.2:p.L858R | EGFR NP_005219.2:p.L861Q | EGFR NP_005219.2:p.G719X
Item
confirmation prior to enrolment into the study that the tumour harbours the following egfr mutations known to be associated with egfr-targeted tki sensitivity: ex19del, l858r, l861q, and g719x.
boolean
C0027651 (UMLS CUI [1])
C3273083 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
C3274186 (UMLS CUI [4])
C3830332 (UMLS CUI [5])
Neoplasms | EGFR NP_005219.2:p.T790M Gene mutation identification test positive | Disease Progression | First line treatment EGFR-TKI Sensitizing Mutation
Item
patients must have had confirmation that tumour is t790m mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved egfr-targeted tki.
boolean
C0027651 (UMLS CUI [1])
C3274192 (UMLS CUI [2,1])
C1504360 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C3273083 (UMLS CUI [4,2])
WHO performance status scale | Deterioration Absent | Life Expectancy
Item
who performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
boolean
C1298650 (UMLS CUI [1])
C0868945 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Following
Item
treatment with any of the following:
boolean
C0087111 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
Prior Therapy Non-Small Cell Lung Carcinoma Advanced
Item
prior treatment with more than one line of treatment for advanced nsclc.
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
major surgery | Vascular Access Device Placement
Item
major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
boolean
C0679637 (UMLS CUI [1])
C1519955 (UMLS CUI [2])
Palliative course of radiotherapy | Radiation Field | Bone Marrow
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 enrolment.
boolean
C0475092 (UMLS CUI [1])
C1882536 (UMLS CUI [2])
C0005953 (UMLS CUI [3])
Compression of spinal cord | Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Asymptomatic | Metastatic malignant neoplasm to brain Stable status | Steroids
Item
spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C0220650 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0220650 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0038317 (UMLS CUI [5])
Study Subject Participation Status
Item
patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. 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 to the extent possible as permitted by the sponsor of that clinical study.
boolean
C2348568 (UMLS CUI [1])
Involvement with Study Staff
Item
involvement in the planning and conduct of the study (applies to astrazeneca staff or staff at the site).
boolean
C1314939 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0851286 (UMLS CUI [1,3])
Compliance behavior Limited
Item
judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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