ID

14826

Beskrivning

PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02448576

Länk

https://clinicaltrials.gov/show/NCT02448576

Nyckelord

Versioner (1)
  1. 2016-04-30 2016-04-30 -
Uppladdad den

30 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02448576

Engelsk

Eligibility Breast Cancer NCT02448576

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. age of 18 to 65 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. documented advanced breast cancer, clinical and pathological confirmed;
Beskrivning

Advanced breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C3495917
4. immunohistochemical examination:er<1%+, progestin receptor (pr)<1%+, her-2 -/+ or her-2(++)with negative result of fish;
Beskrivning

Immunohistochemistry | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Fluorescent in Situ Hybridization

Datatyp

boolean

Alias
UMLS CUI [1]
C0021044
UMLS CUI [2]
C2919271
UMLS CUI [3]
C2919590
UMLS CUI [4]
C0069515
UMLS CUI [5]
C0162789
5. a response after four to eight cycles of first line chemotherapy;
Beskrivning

Disease Response First line treatment Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0392920
6. life expectancy longer than six months evaluated by investigator;
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. a performance status of 0 to 2, according to the criteria of the world health organization (with a higher score indicating a poorer performance status)
Beskrivning

WHO performance status finding | Score

Datatyp

boolean

Alias
UMLS CUI [1]
C1298651
UMLS CUI [2]
C0449820
8. less than grade 1( common terminology criteria grade version 4.0) of treatment-related toxicities;
Beskrivning

Toxic effect Finding related to participation with treatment Common Terminology Criteria for Adverse Events

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1301588
UMLS CUI [1,3]
C1516728
9. adequate baseline organ function.
Beskrivning

body system or organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of another malignancy.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
2. pregnancy or gestation
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
3. definite diagnosed of central nervous system (cns)or leptomeningeal metastases
Beskrivning

CNS metastases | Metastatic Malignant Neoplasm to the Leptomeninges

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C1704231
4. serious cardiac illness or medical condition
Beskrivning

Heart Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
5. known history of related central nervous system or leptomeningeal disease
Beskrivning

CNS disorder | Leptomeningeal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C3160796
6. cognition impairment or suffering from mental illness
Beskrivning

Impaired cognition | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C0004936
7. demand a long-term oral administration of psychotropic drugs
Beskrivning

Psychotropic Drugs Oral Administration Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0001563
UMLS CUI [1,3]
C0443252
8. have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
Beskrivning

Comorbidity Study Subject Participation Status Limited | Disease Affecting patient safety | Disease | Antiviral Therapy | Liver diseases | Gall Bladder Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
UMLS CUI [3]
C0012634
UMLS CUI [4]
C0280274
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0016977
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Similar models

Eligibility Breast Cancer NCT02448576

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age of 18 to 65 years;
boolean
C0001779 (UMLS CUI [1])
Advanced breast cancer
Item
3. documented advanced breast cancer, clinical and pathological confirmed;
boolean
C3495917 (UMLS CUI [1])
Immunohistochemistry | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Fluorescent in Situ Hybridization
Item
4. immunohistochemical examination:er<1%+, progestin receptor (pr)<1%+, her-2 -/+ or her-2(++)with negative result of fish;
boolean
C0021044 (UMLS CUI [1])
C2919271 (UMLS CUI [2])
C2919590 (UMLS CUI [3])
C0069515 (UMLS CUI [4])
C0162789 (UMLS CUI [5])
Disease Response First line treatment Chemotherapy Regimen
Item
5. a response after four to eight cycles of first line chemotherapy;
boolean
C1704632 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Life Expectancy
Item
6. life expectancy longer than six months evaluated by investigator;
boolean
C0023671 (UMLS CUI [1])
WHO performance status finding | Score
Item
7. a performance status of 0 to 2, according to the criteria of the world health organization (with a higher score indicating a poorer performance status)
boolean
C1298651 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
Toxic effect Finding related to participation with treatment Common Terminology Criteria for Adverse Events
Item
8. less than grade 1( common terminology criteria grade version 4.0) of treatment-related toxicities;
boolean
C0600688 (UMLS CUI [1,1])
C1301588 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
body system or organ function
Item
9. adequate baseline organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms
Item
1. history of another malignancy.
boolean
C0006826 (UMLS CUI [1])
Pregnancy
Item
2. pregnancy or gestation
boolean
C0032961 (UMLS CUI [1])
CNS metastases | Metastatic Malignant Neoplasm to the Leptomeninges
Item
3. definite diagnosed of central nervous system (cns)or leptomeningeal metastases
boolean
C0686377 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Heart Diseases
Item
4. serious cardiac illness or medical condition
boolean
C0018799 (UMLS CUI [1])
CNS disorder | Leptomeningeal disease
Item
5. known history of related central nervous system or leptomeningeal disease
boolean
C0007682 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
Impaired cognition | Mental disorders
Item
6. cognition impairment or suffering from mental illness
boolean
C0338656 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Psychotropic Drugs Oral Administration Long-term
Item
7. demand a long-term oral administration of psychotropic drugs
boolean
C0033978 (UMLS CUI [1,1])
C0001563 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Comorbidity Study Subject Participation Status Limited | Disease Affecting patient safety | Disease | Antiviral Therapy | Liver diseases | Gall Bladder Diseases
Item
8. have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3])
C0280274 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0016977 (UMLS CUI [6])
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