ID

37231

Beschrijving

Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus; ODM derived from: https://clinicaltrials.gov/show/NCT02033538

Link

https://clinicaltrials.gov/show/NCT02033538

Trefwoorden

Versies (2)
  1. 09-07-19 09-07-19 -
  2. 09-07-19 09-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of Esophagus NCT02033538

Engels

Eligibility Squamous Cell Carcinoma of Esophagus NCT02033538

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (siewert type i)
Beschrijving

Squamous cell carcinoma of esophagus | Siewert type I adenocarcinoma of esophagogastric junction

Datatype

boolean

Alias
UMLS CUI [1]
C0279626
UMLS CUI [2]
C2585290
locally advanced disease that is technically operable with curative intent (r0)
Beschrijving

Advanced disease Locally Operable Curative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [1,3]
C0205188
UMLS CUI [1,4]
C1276305
t3, n0 or t1-3, n+ or t4, nx
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
no t1-2, n0
Beschrijving

TNM clinical staging Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C2828389
no inoperable t4 (unequivocal organ involvement)
Beschrijving

TNM clinical staging Inoperable Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C2828389
no distant metastasis, including m1a lymph node status
Beschrijving

Distant metastasis Exclusion | TNM clinical staging Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C2828389
lymph nodes suspicious of m1a status by ct scan, pet scan, or ultrasound must be verified by fine-needle aspiration cytology
Beschrijving

Lymph nodes Suspicious TNM clinical staging CT scan | Lymph nodes Suspicious TNM clinical staging PET scan | Lymph nodes Suspicious TNM clinical staging Ultrasonography | Fine needle aspiration for cytology Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C3258246
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C3258246
UMLS CUI [2,4]
C0032743
UMLS CUI [3,1]
C0024204
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C3258246
UMLS CUI [3,4]
C0041618
UMLS CUI [4,1]
C2236896
UMLS CUI [4,2]
C1514873
no carcinoma of the cervical esophagus
Beschrijving

Carcinoma of cervical part of esophagus Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0345764
UMLS CUI [1,2]
C0332196
obstructive tumors allowed
Beschrijving

Tumors Obstructive allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0683607
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
not suitable to surgery
Beschrijving

Patient Inappropriate Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0543467
cervical esophageal carcinoma(distance of incisor tooth<19cm)
Beschrijving

Carcinoma of cervical part of esophagus | Distance Incisor tooth

Datatype

boolean

Alias
UMLS CUI [1]
C0345764
UMLS CUI [2,1]
C0012751
UMLS CUI [2,2]
C0021156
early esophageal carcinoma(stage i)
Beschrijving

Esophageal carcinoma Early Stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152018
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C1306673
complete esophageal obstruction，esophageal perforation or hematemesis
Beschrijving

ESOPHAGEAL OBSTRUCTION COMPLETE | Esophageal Perforation | Hematemesis

Datatype

boolean

Alias
UMLS CUI [1]
C0743579
UMLS CUI [2]
C0014860
UMLS CUI [3]
C0018926
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
Beschrijving

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Beschrijving

Pregnancy | Breast Feeding | Contraceptive methods Refused

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1705116
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
Beschrijving

Seizures Uncontrolled | Mental disorders Uncontrolled | Loss Self-control behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1517945
UMLS CUI [3,2]
C1321228
history of serious allergic or castor oil allergy
Beschrijving

Allergic Serious | Castor oil allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700624
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0571232
patients who are not suitable to participate in the trial according to researchers
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Squamous Cell Carcinoma of Esophagus NCT02033538

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus | Siewert type I adenocarcinoma of esophagogastric junction
Item
histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (siewert type i)
boolean
C0279626 (UMLS CUI [1])
C2585290 (UMLS CUI [2])
Advanced disease Locally Operable Curative
Item
locally advanced disease that is technically operable with curative intent (r0)
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
TNM clinical staging
Item
t3, n0 or t1-3, n+ or t4, nx
boolean
C3258246 (UMLS CUI [1])
TNM clinical staging Exclusion
Item
no t1-2, n0
boolean
C3258246 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
TNM clinical staging Inoperable Exclusion
Item
no inoperable t4 (unequivocal organ involvement)
boolean
C3258246 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Distant metastasis Exclusion | TNM clinical staging Exclusion
Item
no distant metastasis, including m1a lymph node status
boolean
C1269798 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Lymph nodes Suspicious TNM clinical staging CT scan | Lymph nodes Suspicious TNM clinical staging PET scan | Lymph nodes Suspicious TNM clinical staging Ultrasonography | Fine needle aspiration for cytology Required
Item
lymph nodes suspicious of m1a status by ct scan, pet scan, or ultrasound must be verified by fine-needle aspiration cytology
boolean
C0024204 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C0024204 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
C0024204 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
C0041618 (UMLS CUI [3,4])
C2236896 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Carcinoma of cervical part of esophagus Excluded
Item
no carcinoma of the cervical esophagus
boolean
C0345764 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Tumors Obstructive allowed
Item
obstructive tumors allowed
boolean
C0027651 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Patient Inappropriate Operative Surgical Procedures
Item
not suitable to surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Carcinoma of cervical part of esophagus | Distance Incisor tooth
Item
cervical esophageal carcinoma(distance of incisor tooth<19cm)
boolean
C0345764 (UMLS CUI [1])
C0012751 (UMLS CUI [2,1])
C0021156 (UMLS CUI [2,2])
Esophageal carcinoma Early Stage
Item
early esophageal carcinoma(stage i)
boolean
C0152018 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
ESOPHAGEAL OBSTRUCTION COMPLETE | Esophageal Perforation | Hematemesis
Item
complete esophageal obstruction，esophageal perforation or hematemesis
boolean
C0743579 (UMLS CUI [1])
C0014860 (UMLS CUI [2])
C0018926 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Contraceptive methods Refused
Item
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Seizures Uncontrolled | Mental disorders Uncontrolled | Loss Self-control behavior
Item
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1517945 (UMLS CUI [3,1])
C1321228 (UMLS CUI [3,2])
Allergic Serious | Castor oil allergy
Item
history of serious allergic or castor oil allergy
boolean
C0700624 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0571232 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
patients who are not suitable to participate in the trial according to researchers
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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