ID

36599

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01707888

Trefwoorden

  1. 25-05-19 25-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 mei 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.

Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Non-small Cell Lung Cancer NCT01707888

Eligibility Non-small Cell Lung Cancer NCT01707888

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
preoperative criteria:
Beschrijving

Criteria Preoperative

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

Thoracotomy Ipsilateral Absent | Diagnostic Thoracoscopy allowed

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Bacterial Infection | Mycoses

Datatype

boolean

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

Malignant Neoplasms Double Simultaneous | Metachronous Second Primary Neoplasms

Datatype

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.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Pneumonia, Interstitial | Pulmonary Fibrosis | Pulmonary Emphysema Severe

Datatype

boolean

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

Psychotic Disorders

Datatype

boolean

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

Systemic steroids

Datatype

boolean

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

Diabetic - poor control

Datatype

boolean

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

uncontrolled hypertension

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Similar models

Eligibility Non-small Cell Lung Cancer NCT01707888

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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