Eligibility Esophageal Squamous Cell Carcinoma NCT01258192

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of squamous cell carcinoma of esophagus. preoperative stage ⅱ-ⅲ
Beschrijving

Squamous cell carcinoma of esophagus Preoperative TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279626
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C3258246
by endoscopic ultrasound, ct of the chest and abdomen,and esophagogram.
Beschrijving

Endoscopic Ultrasound | CT of chest and abdomen | Esophagram

Datatype

boolean

Alias
UMLS CUI [1]
C0376443
UMLS CUI [2]
C1630402
UMLS CUI [3]
C1318509
age ranges from 18 to 70 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must not have received any prior anticancer therapy.
Beschrijving

Cancer treatment Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
performance status of 0 to 1
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
estimated life expectancy of at least 6 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
tumor can be measured according to recist criteria
Beschrijving

Neoplasm Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513040
signed informed consent document on file.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
females with childbearing potential must have a negative serum pregnancy
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
adequate organ function including the following:
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
bone marrow: absolute neutrophil count (anc) greater than or equal 1.5×109/l platelets greater than or equal 80×109/l haemoglobin greater than or equal 80g/l hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln), alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0232741
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0232804
UMLS CUI [10]
C2711451
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
carcinoma at the upper part of esophagus
Beschrijving

Carcinoma of upper third of esophagus

Datatype

boolean

Alias
UMLS CUI [1]
C0345779
histologic diagnosis of adenocarcinoma of esophagus.
Beschrijving

Adenocarcinoma Of Esophagus

Datatype

boolean

Alias
UMLS CUI [1]
C0279628
prior treatment for esophageal cancer.
Beschrijving

Prior Therapy Esophageal carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0152018
active infection.
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or breast feeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of significant neurological or mental disorder, including seizures or dementia.
Beschrijving

Nervous system disorder | Mental disorders | Seizures | Dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0497327
prior invasive malignancy in 5 years (except for carcinoma in situ).
Beschrijving

invasive cancer | Exception Carcinoma in Situ

Datatype

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099

Similar models

Eligibility Esophageal Squamous Cell Carcinoma NCT01258192

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus Preoperative TNM clinical staging
Item
histologic diagnosis of squamous cell carcinoma of esophagus. preoperative stage ⅱ-ⅲ
boolean
C0279626 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Endoscopic Ultrasound | CT of chest and abdomen | Esophagram
Item
by endoscopic ultrasound, ct of the chest and abdomen,and esophagogram.
boolean
C0376443 (UMLS CUI [1])
C1630402 (UMLS CUI [2])
C1318509 (UMLS CUI [3])
Age
Item
age ranges from 18 to 70 years.
boolean
C0001779 (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])
Performance status
Item
performance status of 0 to 1
boolean
C1518965 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
Neoplasm Measurable
Item
tumor can be measured according to recist criteria
boolean
C0027651 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent document on file.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
females with childbearing potential must have a negative serum pregnancy
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Organ function
Item
adequate organ function including the following:
boolean
C0678852 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
bone marrow: absolute neutrophil count (anc) greater than or equal 1.5×109/l platelets greater than or equal 80×109/l haemoglobin greater than or equal 80g/l hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln), alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C2711451 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Carcinoma of upper third of esophagus
Item
carcinoma at the upper part of esophagus
boolean
C0345779 (UMLS CUI [1])
Adenocarcinoma Of Esophagus
Item
histologic diagnosis of adenocarcinoma of esophagus.
boolean
C0279628 (UMLS CUI [1])
Prior Therapy Esophageal carcinoma
Item
prior treatment for esophageal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0152018 (UMLS CUI [1,2])
Communicable Disease
Item
active infection.
boolean
C0009450 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Nervous system disorder | Mental disorders | Seizures | Dementia
Item
history of significant neurological or mental disorder, including seizures or dementia.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
invasive cancer | Exception Carcinoma in Situ
Item
prior invasive malignancy in 5 years (except for carcinoma in situ).
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])