ID

4918

Description

ODM derived from http://clinicaltrials.gov/show/NCT00518895

Link

http://clinicaltrials.gov/show/NCT00518895

Keywords

Versions (3)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003621 NCT00518895 Melanoma

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
Histologically confirmed diagnosis of melanoma
Description

Histologically confirmed diagnosis of melanoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
Progressive disease that is not surgically resectable, or metastatic Stage IV
Description

Progressive disease that is not surgically resectable, or metastatic Stage IV

Data type

boolean

Alias
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1514888
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0441970
SNOMED CT 2011_0131
258299008
Low-normal LDH, defined as <= 0.8 times the upper limit of normal
Description

Low-normal LDH, defined as <= 0.8 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0205251
SNOMED CT 2011_0131
62482003
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
UMLS CUI 2011AA
C0022917
SNOMED CT 2011_0131
259319003
LOINC Version 232
MTHU002348
UMLS CUI 2011AA
C1519815
No prior chemotherapy
Description

No prior chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Measurable Disease
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1513041
ECOG performance status finding <= 1
Description

ECOG performance status <= 1

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
Description

At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0241311
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C2004454
UMLS CUI 2011AA
CL330043
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0079189
SNOMED CT 2011_0131
75777003
LOINC Version 232
MTHU018469
UMLS CUI 2011AA
C0005527
UMLS CUI 2011AA
C0042209
Prior immunotherapy allowed
Description

Prior immunotherapy allowed

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C1524004
Adequate organ function
Description

Adequate organ function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
Description

Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1571591
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0935954
UMLS CUI 2011AA
C0039798
Primary ocular or mucosal melanoma
Description

Primary ocular or mucosal melanoma

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0558356
SNOMED CT 2011_0131
274087000
MedDRA 14.1
10030052
UMLS CUI 2011AA
CL388343
Metastatic Malignant Neoplasm to the Bone
Description

Bone-only metastatic disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0153690
SNOMED CT 2011_0131
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
History or presence of brain metastasis or leptomeningeal disease
Description

History or presence of brain metastasis or leptomeningeal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
Significant medical disease other than cancer
Description

Significant medical disease other than cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Organ allograft
Description

Organ allograft

Data type

boolean

Alias
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0522536
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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)
Histologically confirmed diagnosis of melanoma
Item
Histologically confirmed diagnosis of melanoma
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Progressive disease that is not surgically resectable, or metastatic Stage IV
Item
Progressive disease that is not surgically resectable, or metastatic Stage IV
boolean
C1335499 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1514888 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0441970 (UMLS CUI 2011AA)
258299008 (SNOMED CT 2011_0131)
Low-normal LDH, defined as <= 0.8 times the upper limit of normal
Item
Low-normal LDH, defined as <= 0.8 times the upper limit of normal
boolean
C0205251 (UMLS CUI 2011AA)
62482003 (SNOMED CT 2011_0131)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
C0022917 (UMLS CUI 2011AA)
259319003 (SNOMED CT 2011_0131)
MTHU002348 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
No prior chemotherapy
Item
No prior chemotherapy
boolean
C1518422 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Measurable disease
Item
Measurable Disease
boolean
C1513041 (UMLS CUI 2011AA)
ECOG performance status <= 1
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
Item
At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
boolean
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
CL330043 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0079189 (UMLS CUI 2011AA)
75777003 (SNOMED CT 2011_0131)
MTHU018469 (LOINC Version 232)
C0005527 (UMLS CUI 2011AA)
C0042209 (UMLS CUI 2011AA)
Prior immunotherapy allowed
Item
Prior immunotherapy allowed
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
Adequate organ function
Item
Adequate organ function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
Item
Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1571591 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0935954 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Primary ocular or mucosal melanoma
Item
Primary ocular or mucosal melanoma
boolean
CL414904 (UMLS CUI 2011AA)
C0558356 (UMLS CUI 2011AA)
274087000 (SNOMED CT 2011_0131)
10030052 (MedDRA 14.1)
CL388343 (UMLS CUI 2011AA)
Bone-only metastatic disease
Item
Metastatic Malignant Neoplasm to the Bone
boolean
C0153690 (UMLS CUI 2011AA)
94222008 (SNOMED CT 2011_0131)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
History or presence of brain metastasis or leptomeningeal disease
Item
History or presence of brain metastasis or leptomeningeal disease
boolean
C0220650 (UMLS CUI 2011AA)
Significant medical disease other than cancer
Item
Significant medical disease other than cancer
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Organ allograft
Item
Organ allograft
boolean
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0522536 (UMLS CUI 2011AA)
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