ID

4427

Description

ODM derived from http://clinicaltrials.gov/show/NCT00796757

Link

http://clinicaltrials.gov/show/NCT00796757

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00796757 Renal Cell 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
adult patients, >=18 years of age
Description

adult patients, >=18 years of age

Data type

boolean

metastatic RCC with majority (>50%) of conventional clear-cell type
Description

metastatic RCC with majority (>50%) of conventional clear-cell type

Data type

boolean

Alias
UMLS CUI 2011AA
C0278678
MedDRA 14.1
10050513
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0680220
UMLS CUI 2011AA
C0279702
SNOMED CT 2011_0131
254915003
MedDRA 14.1
10009251
prior total nephrectomy for primary RCC
Description

prior total nephrectomy for primary RCC

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0176996
SNOMED CT 2011_0131
175905003
ICD-9-CM Version 2011
55.5
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0007134
SNOMED CT 2011_0131
41607009
MedDRA 14.1
10067946
at least one measurable or non-measurable lesions
Description

at least one measurable or non-measurable lesions

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1334988
ECOG performance score of 0 or 2.
Description

ECOG performance score of 0 or 2.

Data type

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1828242
SNOMED CT 2011_0131
422894000
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
prior systemic treatment for metastatic RCC
Description

prior systemic treatment for metastatic RCC

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0278678
MedDRA 14.1
10050513
current or previously treated but non-stable CNS metastases or spinal cord compression
Description

current or previously treated but non-stable CNS metastases or spinal cord compression

Data type

boolean

Alias
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0279130
SNOMED CT 2011_0131
261731003
UMLS CUI 2011AA
C0037926
SNOMED CT 2011_0131
71286001
MedDRA 14.1
10041549
ICD-10-CM Version 2010
G95.20
major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment
Description

major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0184922
SNOMED CT 2011_0131
119283008
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
significant cardiovascular disease within 6 months prior to enrollment.
Description

significant cardiovascular disease within 6 months prior to enrollment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
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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)
adult patients, >=18 years of age
Item
adult patients, >=18 years of age
boolean
metastatic RCC with majority (>50%) of conventional clear-cell type
Item
metastatic RCC with majority (>50%) of conventional clear-cell type
boolean
C0278678 (UMLS CUI 2011AA)
10050513 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0680220 (UMLS CUI 2011AA)
C0279702 (UMLS CUI 2011AA)
254915003 (SNOMED CT 2011_0131)
10009251 (MedDRA 14.1)
prior total nephrectomy for primary RCC
Item
prior total nephrectomy for primary RCC
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0176996 (UMLS CUI 2011AA)
175905003 (SNOMED CT 2011_0131)
55.5 (ICD-9-CM Version 2011)
CL414904 (UMLS CUI 2011AA)
C0007134 (UMLS CUI 2011AA)
41607009 (SNOMED CT 2011_0131)
10067946 (MedDRA 14.1)
at least one measurable or non-measurable lesions
Item
at least one measurable or non-measurable lesions
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1334988 (UMLS CUI 2011AA)
ECOG performance score of 0 or 2.
Item
ECOG performance score of 0 or 2.
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1828242 (UMLS CUI 2011AA)
422894000 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
prior systemic treatment for metastatic RCC
Item
prior systemic treatment for metastatic RCC
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0278678 (UMLS CUI 2011AA)
10050513 (MedDRA 14.1)
current or previously treated but non-stable CNS metastases or spinal cord compression
Item
current or previously treated but non-stable CNS metastases or spinal cord compression
boolean
C2827774 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0279130 (UMLS CUI 2011AA)
261731003 (SNOMED CT 2011_0131)
C0037926 (UMLS CUI 2011AA)
71286001 (SNOMED CT 2011_0131)
10041549 (MedDRA 14.1)
G95.20 (ICD-10-CM Version 2010)
major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment
Item
major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment
boolean
C0679637 (UMLS CUI 2011AA)
C0184922 (UMLS CUI 2011AA)
119283008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
significant cardiovascular disease within 6 months prior to enrollment.
Item
significant cardiovascular disease within 6 months prior to enrollment.
boolean
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
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