ID

37981

Beskrivning

The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC; ODM derived from: https://clinicaltrials.gov/show/NCT01378533

Länk

https://clinicaltrials.gov/show/NCT01378533

Nyckelord

Versioner (1)
  1. 2019-09-05 2019-09-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 september 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT01378533

Engelsk

Eligibility Breast Cancer NCT01378533

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must accept the modified radical mastectomy
Beskrivning

Consent Modified radical mastectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0024883
2. patients with histologically confirmed er(-) pr(-) and her-2(-)
Beskrivning

Estrogen receptor negative | Progesterone receptor negative | HER2 Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0279756
UMLS CUI [2]
C0279766
UMLS CUI [3]
C2348908
3. positive axillary lymph nodes;negative axillary lymph node with age＜ 35 years or ⅲ
Beskrivning

Positive Axillary Lymph Node | Negative Axillary Lymph Node | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0677929
UMLS CUI [2]
C0279781
UMLS CUI [3]
C0001779
grade or intravascular cancer embolus.
Beskrivning

TNM clinical staging | Cancer Embolus

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1704212
4. age between 18 years to 65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. able to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. patients with an eastern cooperative oncology group (ecog) performance score of 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. not pregnant, and on appropriate birth control if of child-bearing potential.
Beskrivning

Pregnancy Absent | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
8. adequate bone marrow reserve with anc > 1000 and platelets > 100,000.
Beskrivning

Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
9. adequate renal function with serum creatinine < 2.0.
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
10. adequate hepatic reserve with serum bilirubin < 2.0, ast/alt < 2x the upper limit of normal, and alkaline phosphatase < 5x the upper limit of normal. serum bilirubin > 2.0 is acceptable in the setting of known gilbert's syndrome.
Beskrivning

Liver function Mass | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C1306372
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0017551
11. no active major medical or psychosocial problems that could be complicated by study participation.
Beskrivning

Medical problem Major Absent | Psychosocial problem Major Absent | Study Subject Participation Status Free of Complications

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0740697
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0332296
UMLS CUI [3,3]
C0009566
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. received neo-adjuvant therapy
Beskrivning

Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0600558
2. cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (muga) scan, or 45% by echocardiogram.-the rate of disease recurrence
Beskrivning

Cardiac dysfunction | Decreased cardiac ejection fraction MUGA scan | Decreased cardiac ejection fraction Echocardiography | Disease recurrence Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2,1]
C3661817
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C3661817
UMLS CUI [3,2]
C0013516
UMLS CUI [4,1]
C0679254
UMLS CUI [4,2]
C1521828
3. uncontrolled medical problems.
Beskrivning

Medical problem Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205318
4. evidence of active acute or chronic infection.
Beskrivning

Communicable Disease | Chronic infectious disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
5. pregnant or breast feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. hepatic, renal, or bone marrow dysfunction as detailed above.
Beskrivning

Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C3887504
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01378533

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Consent Modified radical mastectomy
Item
1. patient must accept the modified radical mastectomy
boolean
C1511481 (UMLS CUI [1,1])
C0024883 (UMLS CUI [1,2])
Estrogen receptor negative | Progesterone receptor negative | HER2 Negative
Item
2. patients with histologically confirmed er(-) pr(-) and her-2(-)
boolean
C0279756 (UMLS CUI [1])
C0279766 (UMLS CUI [2])
C2348908 (UMLS CUI [3])
Positive Axillary Lymph Node | Negative Axillary Lymph Node | Age
Item
3. positive axillary lymph nodes;negative axillary lymph node with age＜ 35 years or ⅲ
boolean
C0677929 (UMLS CUI [1])
C0279781 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
TNM clinical staging | Cancer Embolus
Item
grade or intravascular cancer embolus.
boolean
C3258246 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1704212 (UMLS CUI [2,2])
Age
Item
4. age between 18 years to 65 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
5. able to give informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
6. patients with an eastern cooperative oncology group (ecog) performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
7. not pregnant, and on appropriate birth control if of child-bearing potential.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement
Item
8. adequate bone marrow reserve with anc > 1000 and platelets > 100,000.
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
9. adequate renal function with serum creatinine < 2.0.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function Mass | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Gilbert Disease
Item
10. adequate hepatic reserve with serum bilirubin < 2.0, ast/alt < 2x the upper limit of normal, and alkaline phosphatase < 5x the upper limit of normal. serum bilirubin > 2.0 is acceptable in the setting of known gilbert's syndrome.
boolean
C0232741 (UMLS CUI [1,1])
C1306372 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0017551 (UMLS CUI [6])
Medical problem Major Absent | Psychosocial problem Major Absent | Study Subject Participation Status Free of Complications
Item
11. no active major medical or psychosocial problems that could be complicated by study participation.
boolean
C1254481 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0740697 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0009566 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Neoadjuvant Therapy
Item
1. received neo-adjuvant therapy
boolean
C0600558 (UMLS CUI [1])
Cardiac dysfunction | Decreased cardiac ejection fraction MUGA scan | Decreased cardiac ejection fraction Echocardiography | Disease recurrence Rate
Item
2. cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (muga) scan, or 45% by echocardiogram.-the rate of disease recurrence
boolean
C3277906 (UMLS CUI [1])
C3661817 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C3661817 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0679254 (UMLS CUI [4,1])
C1521828 (UMLS CUI [4,2])
Medical problem Uncontrolled
Item
3. uncontrolled medical problems.
boolean
C1254481 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Communicable Disease | Chronic infectious disease
Item
4. evidence of active acute or chronic infection.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
5. pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction
Item
6. hepatic, renal, or bone marrow dysfunction as detailed above.
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial