ID

36599

Beskrivning

VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01707888

Länk

https://clinicaltrials.gov/show/NCT01707888

Nyckelord

Versioner (1)
  1. 2019-05-25 2019-05-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01707888

Engelsk

Eligibility Non-small Cell Lung Cancer NCT01707888

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
preoperative criteria:
Beskrivning

Criteria Preoperative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0445204
i) non-small cell lung cancer is suspected, ii) clinical stage i/ii (3) intraoperative criteria: i) histologically confirmed nsclc, ii) resected by vats or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
Beskrivning

Non-Small Cell Lung Carcinoma Suspected | TNM clinical staging | Criteria Intraoperative | Non-Small Cell Lung Carcinoma | Excision VATS | Lobectomy | Sleeve Lobectomy | Pneumonectomy | Lymph node excision | Sampling of lymph node

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C0456904
UMLS CUI [4]
C0007131
UMLS CUI [5,1]
C0728940
UMLS CUI [5,2]
C0752151
UMLS CUI [6]
C0023928
UMLS CUI [7]
C0396585
UMLS CUI [8]
C0032284
UMLS CUI [9]
C0024203
UMLS CUI [10]
C0398417
(4) no prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
Beskrivning

Thoracotomy Ipsilateral Absent | Diagnostic Thoracoscopy allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1880308
UMLS CUI [2,2]
C0683607
(5) no prior chemotherapy or radiation therapy for any malignant diseases. (6) expected postoperative fev1.0>=800 ml and pao2>=65 torr. (7) performance status of 0 or 1. (8) sufficient organ functions. (9) written informed consent.
Beskrivning

Prior Chemotherapy Absent Malignant disease | Prior radiation therapy Absent Malignant disease | Expected FEV1 Postoperative | PaO2 | Performance status | Organ function | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0442867
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0442867
UMLS CUI [3,1]
C0588029
UMLS CUI [3,2]
C0032790
UMLS CUI [4]
C0202155
UMLS CUI [5]
C1518965
UMLS CUI [6]
C0678852
UMLS CUI [7]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active bacterial or fungous infection.
Beskrivning

Bacterial Infection | Mycoses

Datatyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0026946
2. simultaneous or metachronous (within the past 5 years) double cancers.
Beskrivning

Malignant Neoplasms Double Simultaneous | Metachronous Second Primary Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C0521115
UMLS CUI [2]
C0085183
3. women during pregnancy or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
Beskrivning

Pneumonia, Interstitial | Pulmonary Fibrosis | Pulmonary Emphysema Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
UMLS CUI [3,1]
C0034067
UMLS CUI [3,2]
C0205082
5. psychosis.
Beskrivning

Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
6. systemic steroids medication.
Beskrivning

Systemic steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
7. uncontrollable diabetes mellitus.
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
8. uncontrollable hypertension.
Beskrivning

uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
9. history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Beskrivning

Heart Disease Severe | Heart failure | Myocardial Infarction | Anginal attack

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0235462
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01707888

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Preoperative
Item
preoperative criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma Suspected | TNM clinical staging | Criteria Intraoperative | Non-Small Cell Lung Carcinoma | Excision VATS | Lobectomy | Sleeve Lobectomy | Pneumonectomy | Lymph node excision | Sampling of lymph node
Item
i) non-small cell lung cancer is suspected, ii) clinical stage i/ii (3) intraoperative criteria: i) histologically confirmed nsclc, ii) resected by vats or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
boolean
C0007131 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0243161 (UMLS CUI [3,1])
C0456904 (UMLS CUI [3,2])
C0007131 (UMLS CUI [4])
C0728940 (UMLS CUI [5,1])
C0752151 (UMLS CUI [5,2])
C0023928 (UMLS CUI [6])
C0396585 (UMLS CUI [7])
C0032284 (UMLS CUI [8])
C0024203 (UMLS CUI [9])
C0398417 (UMLS CUI [10])
Thoracotomy Ipsilateral Absent | Diagnostic Thoracoscopy allowed
Item
(4) no prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
boolean
C0039991 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1880308 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Prior Chemotherapy Absent Malignant disease | Prior radiation therapy Absent Malignant disease | Expected FEV1 Postoperative | PaO2 | Performance status | Organ function | Informed Consent
Item
(5) no prior chemotherapy or radiation therapy for any malignant diseases. (6) expected postoperative fev1.0>=800 ml and pao2>=65 torr. (7) performance status of 0 or 1. (8) sufficient organ functions. (9) written informed consent.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0442867 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0442867 (UMLS CUI [2,3])
C0588029 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0202155 (UMLS CUI [4])
C1518965 (UMLS CUI [5])
C0678852 (UMLS CUI [6])
C0021430 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Bacterial Infection | Mycoses
Item
1. active bacterial or fungous infection.
boolean
C0004623 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
Malignant Neoplasms Double Simultaneous | Metachronous Second Primary Neoplasms
Item
2. simultaneous or metachronous (within the past 5 years) double cancers.
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0085183 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
3. women during pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pneumonia, Interstitial | Pulmonary Fibrosis | Pulmonary Emphysema Severe
Item
4. interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
C0034067 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Psychotic Disorders
Item
5. psychosis.
boolean
C0033975 (UMLS CUI [1])
Systemic steroids
Item
6. systemic steroids medication.
boolean
C2825233 (UMLS CUI [1])
Diabetic - poor control
Item
7. uncontrollable diabetes mellitus.
boolean
C0421258 (UMLS CUI [1])
uncontrolled hypertension
Item
8. uncontrollable hypertension.
boolean
C1868885 (UMLS CUI [1])
Heart Disease Severe | Heart failure | Myocardial Infarction | Anginal attack
Item
9. history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0235462 (UMLS CUI [4])
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