ID

16507

Description

Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT00180921

Link

https://clinicaltrials.gov/show/NCT00180921

Keywords

Versions (1)
  1. 7/21/16 7/21/16 -
Uploaded on

July 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Cancer of the Head and Neck NCT00180921

English

Eligibility Cancer of the Head and Neck NCT00180921

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven adenoid cystic carcinoma overexpressing kit (by immunohistochemistry) with recurrent disease documented by computed tomography (ct) scan or magnetic resonance imaging (mri).
Description

Adenoid Cystic Carcinoma | Overexpression KIT | Immunohistochemistry | Recurrent disease | X-Ray Computed Tomography | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0010606
UMLS CUI [2,1]
C1514559
UMLS CUI [2,2]
C1416655
UMLS CUI [3]
C0021044
UMLS CUI [4]
C0277556
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0024485
presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on ct or mri scan done within 4 weeks before the start of treatment).
Description

Target Lesion Measurable | Contrast Enhancing Lesion | Diameter size | X-Ray Computed Tomography | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C3830314
UMLS CUI [3,1]
C1301886
UMLS CUI [3,2]
C0456389
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
patients able to swallow an oral compound.
Description

Able to swallow oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
world health organization (who) performance status < 2.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy of >= 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
aged >= 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions.
Description

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Transaminases | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201850
UMLS CUI [7]
C0002594
UMLS CUI [8]
C0232804
UMLS CUI [9]
C0201976
written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ecg).
Description

Cardiac function test abnormal | Ischaemic heart disease | 12 lead ECG Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438177
UMLS CUI [2]
C1869045
UMLS CUI [3,1]
C0430456
UMLS CUI [3,2]
C0205161
previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
Description

Malignant Neoplasms Site | Cervix carcinoma Conization | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0195324
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C0205411
concomitant treatment with warfarin or any other anticoagulants.
Description

Warfarin | Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0003280
unstable systemic diseases or active uncontrolled infections.
Description

Systemic disease Unstable | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
patients (male and female) not using effective contraception if of reproductive potential.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
females pregnant or lactating or positive beta human chorionic gonadotropin (bhcg) at baseline
Description

Pregnancy | Breast Feeding | Blood beta human chorionic gonadotropin positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1868907
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Similar models

Eligibility Cancer of the Head and Neck NCT00180921

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenoid Cystic Carcinoma | Overexpression KIT | Immunohistochemistry | Recurrent disease | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
histologically or cytologically proven adenoid cystic carcinoma overexpressing kit (by immunohistochemistry) with recurrent disease documented by computed tomography (ct) scan or magnetic resonance imaging (mri).
boolean
C0010606 (UMLS CUI [1])
C1514559 (UMLS CUI [2,1])
C1416655 (UMLS CUI [2,2])
C0021044 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
Target Lesion Measurable | Contrast Enhancing Lesion | Diameter size | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on ct or mri scan done within 4 weeks before the start of treatment).
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C3830314 (UMLS CUI [2])
C1301886 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Able to swallow oral medication
Item
patients able to swallow an oral compound.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
WHO performance status scale
Item
world health organization (who) performance status < 2.
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of >= 3 months.
boolean
C0023671 (UMLS CUI [1])
Age
Item
aged >= 18 years.
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Transaminases | Renal function | Creatinine measurement, serum
Item
normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
C0002594 (UMLS CUI [7])
C0232804 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiac function test abnormal | Ischaemic heart disease | 12 lead ECG Abnormal
Item
abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ecg).
boolean
C0438177 (UMLS CUI [1])
C1869045 (UMLS CUI [2])
C0430456 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Malignant Neoplasms Site | Cervix carcinoma Conization | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate
Item
previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0302592 (UMLS CUI [2,1])
C0195324 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0205411 (UMLS CUI [4,3])
Warfarin | Anticoagulants
Item
concomitant treatment with warfarin or any other anticoagulants.
boolean
C0043031 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
Systemic disease Unstable | Communicable Disease Uncontrolled
Item
unstable systemic diseases or active uncontrolled infections.
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Females & males of reproductive potential Contraceptive methods
Item
patients (male and female) not using effective contraception if of reproductive potential.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Blood beta human chorionic gonadotropin positive
Item
females pregnant or lactating or positive beta human chorionic gonadotropin (bhcg) at baseline
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1868907 (UMLS CUI [3])
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