ID

39277

Description

Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01688700

Link

https://clinicaltrials.gov/show/NCT01688700

Keywords

Versions (1)
  1. 12/16/19 12/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

English

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytologic diagnosis of esophageal squamous cell carcinoma
Description

Squamous cell carcinoma of esophagus

Data type

boolean

Alias
UMLS CUI [1]
C0279626
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age:18-70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
joined the study voluntarily and signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must not have received any prior anticancer therapy
Description

Cancer treatment Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
resectable disease, stage iia-iiic, t2n0m0-t3n1m0（ajcc 2009）
Description

Disease Resectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C3258246
target lesions can be measured according to recist criteria
Description

Target Lesion Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
no serious system dysfunction and immuno-deficiency, adequate organ function including the following: hemoglobin ≥9 g/dl, wbc≥3x109/l, neutrophils (anc )≥1.5x109/l, platelet count ≥100x 109/l, tbil<1.5 x uln, alt and ast ≦ 2.5 x uln, creatinine ≦ 1.5 x uln
Description

Body system Dysfunction Serious Absent | Immunodeficiency Absent | Organ function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0678852
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0948762
UMLS CUI [7]
C0032181
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201976
use of an effective contraceptive for adults to prevent pregnancy
Description

Contraceptive Agent Adult

Data type

boolean

Alias
UMLS CUI [1,1]
C0009871
UMLS CUI [1,2]
C0001675
life expectancy of more than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
not suitable to surgery
Description

Patient Inappropriate Operative Surgical Procedures

Data type

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)
Description

Carcinoma of cervical part of esophagus

Data type

boolean

Alias
UMLS CUI [1]
C0345764
early esophageal carcinoma(stage i)
Description

Esophageal carcinoma Early TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0152018
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C3258246
complete esophageal obstruction，esophageal perforation or hematemesis
Description

ESOPHAGEAL OBSTRUCTION COMPLETE | Esophageal Perforation | Hematemesis

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding | Contraceptive Agents Refused

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0009871
UMLS CUI [3,2]
C1705116
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 history of serious allergic or castor oil allergy 12、 patients who are not suitable to participate in the trial according to researchers
Description

Seizures Uncontrolled | Mental disorders Uncontrolled | Unable to control behavior | Allergic Reaction Serious Castor Oil | Castor oil allergy | Study Subject Participation Status Inappropriate

Data type

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]
C0582140
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0007343
UMLS CUI [5]
C0571232
UMLS CUI [6,1]
C2348568
UMLS CUI [6,2]
C1548788
Back to the top of the page

Similar models

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus
Item
histological or cytologic diagnosis of esophageal squamous cell carcinoma
boolean
C0279626 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age:18-70 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
joined the study voluntarily and signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Cancer treatment Absent
Item
patients must not have received any prior anticancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Disease Resectable TNM clinical staging
Item
resectable disease, stage iia-iiic, t2n0m0-t3n1m0（ajcc 2009）
boolean
C0012634 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Target Lesion Measurable
Item
target lesions can be measured according to recist criteria
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Body system Dysfunction Serious Absent | Immunodeficiency Absent | Organ function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
no serious system dysfunction and immuno-deficiency, adequate organ function including the following: hemoglobin ≥9 g/dl, wbc≥3x109/l, neutrophils (anc )≥1.5x109/l, platelet count ≥100x 109/l, tbil<1.5 x uln, alt and ast ≦ 2.5 x uln, creatinine ≦ 1.5 x uln
boolean
C0460002 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0021051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
Contraceptive Agent Adult
Item
use of an effective contraceptive for adults to prevent pregnancy
boolean
C0009871 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
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
Item
cervical esophageal carcinoma(distance of incisor tooth<19cm)
boolean
C0345764 (UMLS CUI [1])
Esophageal carcinoma Early TNM clinical staging
Item
early esophageal carcinoma(stage i)
boolean
C0152018 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C3258246 (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 Agents 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])
C0009871 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Seizures Uncontrolled | Mental disorders Uncontrolled | Unable to control behavior | Allergic Reaction Serious Castor Oil | Castor oil allergy | Study Subject Participation Status Inappropriate
Item
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 history of serious allergic or castor oil allergy 12、 patients who are not suitable to participate in the trial according to researchers
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0582140 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0007343 (UMLS CUI [4,3])
C0571232 (UMLS CUI [5])
C2348568 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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