ID

4880

Description

ODM derived from http://clinicaltrials.gov/show/NCT00264056

Link

http://clinicaltrials.gov/show/NCT00264056

Keywords

  1. 2/23/12 2/23/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00264056 Advanced Metastastic Malignant Melanoma Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age between 18 and 70
Description

Age

Data type

boolean

histologically proven malignant melanoma with advanced inoperable soft tissue metastases
Description

malignant melanoma

Data type

boolean

progressive disease upon systemic first-line chemotherapy
Description

systemic first-line chemotherapy

Data type

boolean

2 or more bidimensionally measurable soft tissue lesions
Description

soft tissue lesions

Data type

boolean

WHO performance status (ECOG) of 2 or more
Description

ECOG score 2

Data type

boolean

life expectancy of 8 weeks and more
Description

life expectancy of 8 weeks and more

Data type

boolean

prior informed consent
Description

informed consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

participation in other therapy studies
Description

participation in other therapy studies

Data type

boolean

pregnancy or breast feeding
Description

pregnancy or breast feeding

Data type

boolean

concomitant clinically significant infection
Description

clinically significant infection

Data type

boolean

cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
Description

cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region

Data type

boolean

lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
Description

lack of physiological heat sensitivity within the hyperthermia treated region

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Malignant melanoma
Description

Melanoma

Data type

string

Alias
UMLS CUI
C0025202
SNOMED CT 2010_0731
2092003
MedDRA 13.1
10025650
Secondary malignant neoplasm of soft tissues
Description

soft tissue metastases

Data type

string

Alias
UMLS CUI
C0684686
SNOMED CT 2010_0731
94264008
MedDRA 13.1
10062197
Progressive Disease
Description

Progressive Disease

Data type

string

Alias
UMLS CUI
C1335499
Systemic Chemotherapy
Description

Systemic Chemotherapy

Data type

string

Alias
UMLS CUI
C1883256
Soft tissue lesion
Description

Soft tissue lesion

Data type

string

Alias
UMLS CUI
C0410013
SNOMED CT 2010_0731
239953001
ECOG performance status finding
Description

ECOG

Data type

string

Alias
UMLS CUI
C1520224
SNOMED CT 2010_0731
424122007
ECOG performance status - grade 2
Description

ECOG performance status - grade 2

Data type

string

Alias
UMLS CUI
C1828242
SNOMED CT 2010_0731
422894000
Life expectancy
Description

Life expectancy

Data type

string

Alias
UMLS CUI
C0023671
LOINC Version 232
MTHU021387
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Pregnancy
Description

Pregnancy

Data type

string

Alias
UMLS CUI
C0549206
SNOMED CT 2010_0731
289908002
MedDRA 13.1
10036556
LOINC Version 232
MTHU035048
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Artificial cardiac pacemaker
Description

cardiac pacemaker

Data type

string

Alias
UMLS CUI
C0030163
SNOMED CT 2010_0731
14106009
LOINC Version 232
MTHU024521
Biomedical implant
Description

Implant

Data type

string

Alias
UMLS CUI
C0021102
SNOMED CT 2010_0731
40388003
Hyperthermia Treatment
Description

Hyperthermia Treatment

Data type

string

Alias
UMLS CUI
C0203597
SNOMED CT 2010_0731
31847002
Intolerant of heat
Description

Heat sensitivity

Data type

string

Alias
UMLS CUI
C0231274
SNOMED CT 2010_0731
69215007
MedDRA 13.1
10056596

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
age between 18 and 70
boolean
malignant melanoma
Item
histologically proven malignant melanoma with advanced inoperable soft tissue metastases
boolean
systemic first-line chemotherapy
Item
progressive disease upon systemic first-line chemotherapy
boolean
soft tissue lesions
Item
2 or more bidimensionally measurable soft tissue lesions
boolean
ECOG score 2
Item
WHO performance status (ECOG) of 2 or more
boolean
life expectancy of 8 weeks and more
Item
life expectancy of 8 weeks and more
boolean
informed consent
Item
prior informed consent
boolean
Item Group
Exclusion Criteria
participation in other therapy studies
Item
participation in other therapy studies
boolean
pregnancy or breast feeding
Item
pregnancy or breast feeding
boolean
clinically significant infection
Item
concomitant clinically significant infection
boolean
cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region
Item
cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
boolean
lack of physiological heat sensitivity within the hyperthermia treated region
Item
lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignant melanoma
string
C0025202 (UMLS CUI)
2092003 (SNOMED CT 2010_0731)
10025650 (MedDRA 13.1)
soft tissue metastases
Item
Secondary malignant neoplasm of soft tissues
string
C0684686 (UMLS CUI)
94264008 (SNOMED CT 2010_0731)
10062197 (MedDRA 13.1)
Progressive Disease
Item
Progressive Disease
string
C1335499 (UMLS CUI)
Systemic Chemotherapy
Item
Systemic Chemotherapy
string
C1883256 (UMLS CUI)
Soft tissue lesion
Item
Soft tissue lesion
string
C0410013 (UMLS CUI)
239953001 (SNOMED CT 2010_0731)
ECOG
Item
ECOG performance status finding
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
ECOG performance status - grade 2
Item
ECOG performance status - grade 2
string
C1828242 (UMLS CUI)
422894000 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
MTHU021387 (LOINC Version 232)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Pregnancy
Item
Pregnancy
string
C0549206 (UMLS CUI)
289908002 (SNOMED CT 2010_0731)
10036556 (MedDRA 13.1)
MTHU035048 (LOINC Version 232)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
cardiac pacemaker
Item
Artificial cardiac pacemaker
string
C0030163 (UMLS CUI)
14106009 (SNOMED CT 2010_0731)
MTHU024521 (LOINC Version 232)
Implant
Item
Biomedical implant
string
C0021102 (UMLS CUI)
40388003 (SNOMED CT 2010_0731)
Hyperthermia Treatment
Item
Hyperthermia Treatment
string
C0203597 (UMLS CUI)
31847002 (SNOMED CT 2010_0731)
Heat sensitivity
Item
Intolerant of heat
string
C0231274 (UMLS CUI)
69215007 (SNOMED CT 2010_0731)
10056596 (MedDRA 13.1)

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