ID

36600

Description

TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx); ODM derived from: https://clinicaltrials.gov/show/NCT01888601

Link

https://clinicaltrials.gov/show/NCT01888601

Keywords

Versions (1)
  1. 5/25/19 5/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01888601

English

Eligibility Non-small Cell Lung Cancer NCT01888601

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients ≥18 years of age, with early stage i-iiia disease who are eligible for primary surgery (including stage ia; and stage iiia considered unsuitable for chemoradiation)
Description

Age | Disease TNM clinical staging | Eligibility Operative Surgical Procedure Primary

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0205225
histopathologically confirmed nsclc, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g. diagnosis determined from frozen section in theatre)
Description

Non-Small Cell Lung Carcinoma | Suspicion Malignant Neoplasm Imaging of lung | Operative Surgical Procedure Required

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C2711710
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1514873
primary surgery in keeping with nice guidelines planned
Description

Operative Surgical Procedure Primary Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1301732
agreement to be followed up in a specialist centre
Description

Follow-up Specialist center

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C2348234
UMLS CUI [1,3]
C0565990
performance status 0 or 1
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer and in situ cervical cancer)
Description

Cancer Other | Recurrent Carcinoma | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0549379
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
psychological condition that would preclude informed consent
Description

Mental condition Excludes Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
treatment with neo-adjuvant chemotherapy deemed necessary
Description

Patient need for Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1298676
adjuvant regimen other than platinum-based therapy (if a patient is deemed suitable for adjuvant therapy)
Description

Adjuvant therapy | Exception Therapy Platinum-Based

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1514162
patients infected with blood borne viruses hepatitis c, hepatitis b and/or hiv
Description

Hepatitis C | Hepatitis B | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
sufficient tissue is unlikely to be obtained for the study based on pre-operative imaging
Description

Tissue specimen Sufficient Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0750558
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01888601

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age | Disease TNM clinical staging | Eligibility Operative Surgical Procedure Primary
Item
patients ≥18 years of age, with early stage i-iiia disease who are eligible for primary surgery (including stage ia; and stage iiia considered unsuitable for chemoradiation)
boolean
C0001779 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1548635 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
Non-Small Cell Lung Carcinoma | Suspicion Malignant Neoplasm Imaging of lung | Operative Surgical Procedure Required
Item
histopathologically confirmed nsclc, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g. diagnosis determined from frozen section in theatre)
boolean
C0007131 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C2711710 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Operative Surgical Procedure Primary Planned
Item
primary surgery in keeping with nice guidelines planned
boolean
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Follow-up Specialist center
Item
agreement to be followed up in a specialist centre
boolean
C3274571 (UMLS CUI [1,1])
C2348234 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,3])
Performance status
Item
performance status 0 or 1
boolean
C1518965 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Recurrent Carcinoma | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer and in situ cervical cancer)
boolean
C1707251 (UMLS CUI [1])
C0549379 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Mental condition Excludes Informed Consent
Item
psychological condition that would preclude informed consent
boolean
C3840291 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Patient need for Chemotherapy Neoadjuvant
Item
treatment with neo-adjuvant chemotherapy deemed necessary
boolean
C0686904 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1298676 (UMLS CUI [1,3])
Adjuvant therapy | Exception Therapy Platinum-Based
Item
adjuvant regimen other than platinum-based therapy (if a patient is deemed suitable for adjuvant therapy)
boolean
C0677850 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
Hepatitis C | Hepatitis B | HIV Infection
Item
patients infected with blood borne viruses hepatitis c, hepatitis b and/or hiv
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Tissue specimen Sufficient Unlikely
Item
sufficient tissue is unlikely to be obtained for the study based on pre-operative imaging
boolean
C1292533 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
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