ID

5062

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00987636

Link

http://clinicaltrials.gov/show/NCT00987636

Stichworte

Versionen (2)
  1. 07/12/2013 07/12/2013 - Martin Dugas
  2. 17/04/2014 17/04/2014 - Julian Varghese
Hochgeladen am

17 de abril de 2014

DOI

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Eligibility NCT00987636 Ewing's Sarcoma

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 48 Monate bis 50 Jahre
Beschreibung

age 48 Months to 50 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
Beschreibung

Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0585474
SNOMED CT 2011_0131
307608006
UMLS CUI 2011AA
CL432298
SNOMED CT 2011_0131
447951009
Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
Beschreibung

Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1706086
UMLS CUI 2011AA
C0079399
SNOMED CT 2011_0131
263495000
LOINC Version 232
MTHU002975
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C1518931
SNOMED CT 2011_0131
418002000
UMLS CUI 2011AA
C1690538
SNOMED CT 2011_0131
418652005
UMLS CUI 2011AA
C0011008
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AA
CL415042
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
Registration: <= 45 days after diagnostic biopsy/surgery.
Beschreibung

Registration: <= 45 days after diagnostic biopsy/surgery.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL415042
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0038895
Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
Beschreibung

Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL415042
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0038895
Informed consent: Must be signed prior to study entry.
Beschreibung

Informed consent: Must be signed prior to study entry.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
Beschreibung

Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1522275
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
UMLS CUI 2011AA
C0598558
Haematological parameters:
Beschreibung

Haematological parameters:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C0449381
SNOMED CT 2011_0131
252116004
Haemoglobin > 8 g/dl (transfusion allowed),
Beschreibung

Haemoglobin > 8 g/dl (transfusion allowed),

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
Platelets > 80.000/nicrol (transfusion allowed),
Beschreibung

Platelets > 80.000/nicrol (transfusion allowed),

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0005821
SNOMED CT 2011_0131
16378004
LOINC Version 232
MTHU002432
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
Leukozyt, weiße Blutzelle, weißes Blutkörperchen
Beschreibung

WBC > 2000/nicrol.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0023516
SNOMED CT 2011_0131
52501007
MedDRA 14.1
10047955
LOINC Version 232
MTHU001946
Cardiac values: LVEF > 40%, SF > 28%.
Beschreibung

Cardiac values: LVEF > 40%, SF > 28%.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C1335957
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
> one cycle of other chemotherapy prior to registration
Beschreibung

> one cycle of other chemotherapy prior to registration

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1302181
SNOMED CT 2011_0131
399042005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Neoplasms, Second Primary
Beschreibung

Second malignancy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0085183
Pregnancy and lactation
Beschreibung

Pregnancy and lactation

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
Beschreibung

Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2349179
UMLS CUI 2011AA
C0003297
SNOMED CT 2011_0131
52017007
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
CL025471
UMLS CUI 2011AA
C1521721
Any other medical, psychiatric, or social condition incompatible with protocol treatment
Beschreibung

Any other medical, psychiatric, or social condition incompatible with protocol treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0809986
UMLS CUI 2011AA
C0037403
SNOMED CT 2011_0131
82996008
UMLS CUI 2011AA
C0679426
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0039798
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 48 Months to 50 Years
Item
Alter 48 Monate bis 50 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
Item
Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0585474 (UMLS CUI 2011AA)
307608006 (SNOMED CT 2011_0131)
CL432298 (UMLS CUI 2011AA)
447951009 (SNOMED CT 2011_0131)
Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
Item
Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
boolean
C1706086 (UMLS CUI 2011AA)
C0079399 (UMLS CUI 2011AA)
263495000 (SNOMED CT 2011_0131)
MTHU002975 (LOINC Version 232)
C0037459 (UMLS CUI 2011AA)
C1518931 (UMLS CUI 2011AA)
418002000 (SNOMED CT 2011_0131)
C1690538 (UMLS CUI 2011AA)
418652005 (SNOMED CT 2011_0131)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
CL415042 (UMLS CUI 2011AA)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Registration: <= 45 days after diagnostic biopsy/surgery.
Item
Registration: <= 45 days after diagnostic biopsy/surgery.
boolean
C1516879 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL415042 (UMLS CUI 2011AA)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
Item
Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
boolean
CL414705 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL415042 (UMLS CUI 2011AA)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
Informed consent: Must be signed prior to study entry.
Item
Informed consent: Must be signed prior to study entry.
boolean
C0021430 (UMLS CUI 2011AA)
Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
Item
Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
boolean
C1522275 (UMLS CUI 2011AA)
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
C0598558 (UMLS CUI 2011AA)
Haematological parameters:
Item
Haematological parameters:
boolean
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
Haemoglobin > 8 g/dl (transfusion allowed),
Item
Haemoglobin > 8 g/dl (transfusion allowed),
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
Platelets > 80.000/nicrol (transfusion allowed),
Item
Platelets > 80.000/nicrol (transfusion allowed),
boolean
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
MTHU002432 (LOINC Version 232)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
WBC > 2000/nicrol.
Item
Leukozyt, weiße Blutzelle, weißes Blutkörperchen
boolean
C0023516 (UMLS CUI 2011AA)
52501007 (SNOMED CT 2011_0131)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
Cardiac values: LVEF > 40%, SF > 28%.
Item
Cardiac values: LVEF > 40%, SF > 28%.
boolean
C1522601 (UMLS CUI 2011AA)
C1522609 (UMLS CUI 2011AA)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C1335957 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
> one cycle of other chemotherapy prior to registration
Item
> one cycle of other chemotherapy prior to registration
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1302181 (UMLS CUI 2011AA)
399042005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Second malignancy
Item
Neoplasms, Second Primary
boolean
C0085183 (UMLS CUI 2011AA)
Pregnancy and lactation
Item
Pregnancy and lactation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
Item
Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2349179 (UMLS CUI 2011AA)
C0003297 (UMLS CUI 2011AA)
52017007 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
CL025471 (UMLS CUI 2011AA)
C1521721 (UMLS CUI 2011AA)
Any other medical, psychiatric, or social condition incompatible with protocol treatment
Item
Any other medical, psychiatric, or social condition incompatible with protocol treatment
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0809986 (UMLS CUI 2011AA)
C0037403 (UMLS CUI 2011AA)
82996008 (SNOMED CT 2011_0131)
C0679426 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
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