ID

5055

Description

ODM derived from http://clinicaltrials.gov/show/NCT00964977

Link

http://clinicaltrials.gov/show/NCT00964977

Keywords

Versions (2)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00005506 NCT00964977 Oropharyngeal Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx
Description

histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0585362
SNOMED CT 2011_0131
307502000
MedDRA 14.1
10041857
UMLS CUI 2011AA
C0280313
SNOMED CT 2011_0131
423464009
MedDRA 14.1
10031112
maximum tumor diameter < 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)
Description

maximum tumor diameter < 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)

Data type

boolean

Alias
UMLS CUI 2011AA
C0806909
SNOMED CT 2011_0131
398303009
LOINC Version 232
MTHU008917
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C1298736
SNOMED CT 2011_0131
373372005
UMLS CUI 2011AA
C0332391
SNOMED CT 2011_0131
53786006
UMLS CUI 2011AA
C0332392
SNOMED CT 2011_0131
80898003
concomitant histological verification of a singular ipsilateral lymph node metastasis < 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)
Description

concomitant histological verification of a singular ipsilateral lymph node metastasis < 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C1711411
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0686619
SNOMED CT 2011_0131
94392001
MedDRA 14.1
10027459
ICD-10-CM Version 2010
C77.9
ICD-9-CM Version 2011
196.9
UMLS CUI 2011AA
C0332397
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0948588
MedDRA 14.1
10053132
radical resection of the tumor within adequate resection margins (R0)
Description

radical resection of the tumor within adequate resection margins (R0)

Data type

boolean

Alias
UMLS CUI 2011AA
C0439807
SNOMED CT 2011_0131
255612005
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0229985
SNOMED CT 2011_0131
82868003
written informed consent from the patient
Description

written informed consent from the patient

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
adequate performance status ECOG Index <= 2
Description

adequate performance status ECOG Index <= 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
age < 18 years
Description

an age < 18 years old

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
pregnant women
Description

pregnant women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
reported drug addiction
Description

reported drug addiction

Data type

boolean

intake of remedies with potential influence on compliance or impaired judgment
Description

intake of remedies with potential influence on compliance or impaired judgment

Data type

boolean

Alias
UMLS CUI 2011AA
C1510472
SNOMED CT 2011_0131
191816009
MedDRA 14.1
10013663
ICD-9-CM Version 2011
304
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule
Description

patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule

Data type

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0424945
SNOMED CT 2011_0131
160476009
LOINC Version 232
MTHU014081
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0086960
inadequate performance status ECOG Index > 2
Description

inadequate performance status ECOG Index > 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx
Item
histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL414904 (UMLS CUI 2011AA)
C0585362 (UMLS CUI 2011AA)
307502000 (SNOMED CT 2011_0131)
10041857 (MedDRA 14.1)
C0280313 (UMLS CUI 2011AA)
423464009 (SNOMED CT 2011_0131)
10031112 (MedDRA 14.1)
maximum tumor diameter < 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)
Item
maximum tumor diameter < 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)
boolean
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
MTHU008917 (LOINC Version 232)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C1298736 (UMLS CUI 2011AA)
373372005 (SNOMED CT 2011_0131)
C0332391 (UMLS CUI 2011AA)
53786006 (SNOMED CT 2011_0131)
C0332392 (UMLS CUI 2011AA)
80898003 (SNOMED CT 2011_0131)
concomitant histological verification of a singular ipsilateral lymph node metastasis < 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)
Item
concomitant histological verification of a singular ipsilateral lymph node metastasis < 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C1711411 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0686619 (UMLS CUI 2011AA)
94392001 (SNOMED CT 2011_0131)
10027459 (MedDRA 14.1)
C77.9 (ICD-10-CM Version 2010)
196.9 (ICD-9-CM Version 2011)
C0332397 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0948588 (UMLS CUI 2011AA)
10053132 (MedDRA 14.1)
radical resection of the tumor within adequate resection margins (R0)
Item
radical resection of the tumor within adequate resection margins (R0)
boolean
C0439807 (UMLS CUI 2011AA)
255612005 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
written informed consent from the patient
Item
written informed consent from the patient
boolean
C0021430 (UMLS CUI 2011AA)
adequate performance status ECOG Index <= 2
Item
adequate performance status ECOG Index <= 2
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
an age < 18 years old
Item
age < 18 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
pregnant women
Item
pregnant women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
reported drug addiction
Item
reported drug addiction
boolean
intake of remedies with potential influence on compliance or impaired judgment
Item
intake of remedies with potential influence on compliance or impaired judgment
boolean
C1510472 (UMLS CUI 2011AA)
191816009 (SNOMED CT 2011_0131)
10013663 (MedDRA 14.1)
304 (ICD-9-CM Version 2011)
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule
Item
patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0424945 (UMLS CUI 2011AA)
160476009 (SNOMED CT 2011_0131)
MTHU014081 (LOINC Version 232)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
inadequate performance status ECOG Index > 2
Item
inadequate performance status ECOG Index > 2
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
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