ID

36596

Beschreibung

Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea; ODM derived from: https://clinicaltrials.gov/show/NCT02196675

Link

https://clinicaltrials.gov/show/NCT02196675

Stichworte

Versionen (1)
  1. 25.05.19 25.05.19 -
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See clinicaltrials.gov

Hochgeladen am

25. Mai 2019

DOI

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Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02196675

Englisch

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02196675

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
Beschreibung

Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0184909
UMLS CUI [3,2]
C0752151
scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
Beschreibung

Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0396565
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0396565
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0225752
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0023928
UMLS CUI [4]
C0184909
performance status 0-1 (eastern cooperative oncology group classification);
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
asa score ≤ 3;
Beschreibung

American Society of Anesthesiologists physical status classification

Datentyp

boolean

Alias
UMLS CUI [1]
C1531480
no prior history of vats or open lung surgery;
Beschreibung

Video-Assisted Thoracic Surgery Previous Absent | Open Surgical Procedure Lung Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0752151
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C4283938
UMLS CUI [2,2]
C0024109
UMLS CUI [2,3]
C0332197
willing to give consent and comply with study-related evaluation and treatment schedule; and
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
at least 19 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Beschreibung

Systemic therapy Bacterial Infections | Systemic therapy Mycoses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0004623
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0026946
systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure);
Beschreibung

Systemic steroids Intravenous | Systemic steroids Oral | Herbal Supplements Containing Steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1504473
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0038317
chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure;
Beschreibung

Chemotherapy Absent Carcinoma of lung | Therapeutic radiology procedure Absent Carcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0684249
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0684249
scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and vats lymphadenectomy are allowed);
Beschreibung

Operative Surgical Procedures Scheduled | Exception Wedge resection | Exception Lobectomy | Central Venous Access allowed | Portacath Placement allowed | Mediastinoscopy allowed | Sampling of lymph node allowed | Lymph node excision VATS allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0184909
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023928
UMLS CUI [4,1]
C1610672
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C1514239
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0025065
UMLS CUI [6,2]
C0683607
UMLS CUI [7,1]
C0398417
UMLS CUI [7,2]
C0683607
UMLS CUI [8,1]
C0024203
UMLS CUI [8,2]
C0752151
UMLS CUI [8,3]
C0683607
pregnancy;
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
physical or psychological condition which would impair study participation;
Beschreibung

Physical Condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C2348568
the patient is judged unsuitable for study participation by the investigator for any other reason; or
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
unable or unwilling to attend follow-up visits and examinations.
Beschreibung

Follow-up visit Unable | Follow-up visit Unwilling | Follow-up examination Unable | Follow-up examination Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0260832
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0260832
UMLS CUI [4,2]
C0558080
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02196675

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS
Item
suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
boolean
C0007131 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0184909 (UMLS CUI [3,1])
C0752151 (UMLS CUI [3,2])
Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection
Item
scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
boolean
C0396565 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0396565 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0225752 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0023928 (UMLS CUI [3])
C0184909 (UMLS CUI [4])
ECOG performance status
Item
performance status 0-1 (eastern cooperative oncology group classification);
boolean
C1520224 (UMLS CUI [1])
American Society of Anesthesiologists physical status classification
Item
asa score ≤ 3;
boolean
C1531480 (UMLS CUI [1])
Video-Assisted Thoracic Surgery Previous Absent | Open Surgical Procedure Lung Absent
Item
no prior history of vats or open lung surgery;
boolean
C0752151 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C4283938 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
willing to give consent and comply with study-related evaluation and treatment schedule; and
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Age
Item
at least 19 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Bacterial Infections | Systemic therapy Mycoses
Item
active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
boolean
C1515119 (UMLS CUI [1,1])
C0004623 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0026946 (UMLS CUI [2,2])
Systemic steroids Intravenous | Systemic steroids Oral | Herbal Supplements Containing Steroids
Item
systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure);
boolean
C2825233 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1504473 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0038317 (UMLS CUI [3,3])
Chemotherapy Absent Carcinoma of lung | Therapeutic radiology procedure Absent Carcinoma of lung
Item
chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure;
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0684249 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0684249 (UMLS CUI [2,3])
Operative Surgical Procedures Scheduled | Exception Wedge resection | Exception Lobectomy | Central Venous Access allowed | Portacath Placement allowed | Mediastinoscopy allowed | Sampling of lymph node allowed | Lymph node excision VATS allowed
Item
scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and vats lymphadenectomy are allowed);
boolean
C0543467 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0184909 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023928 (UMLS CUI [3,2])
C1610672 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C1514239 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0025065 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0398417 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C0024203 (UMLS CUI [8,1])
C0752151 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Physical Condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status
Item
physical or psychological condition which would impair study participation;
boolean
C3714565 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate
Item
the patient is judged unsuitable for study participation by the investigator for any other reason; or
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Follow-up visit Unable | Follow-up visit Unwilling | Follow-up examination Unable | Follow-up examination Unwilling
Item
unable or unwilling to attend follow-up visits and examinations.
boolean
C0589121 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0260832 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0260832 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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