ID

37981

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01378533

Trefwoorden

Versies (1)
  1. 05-09-19 05-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01378533

Engels

Eligibility Breast Cancer NCT01378533

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Consent Modified radical mastectomy

Datatype

boolean

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

Estrogen receptor negative | Progesterone receptor negative | HER2 Negative

Datatype

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
Beschrijving

Positive Axillary Lymph Node | Negative Axillary Lymph Node | Age

Datatype

boolean

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

TNM clinical staging | Cancer Embolus

Datatype

boolean

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

Age

Datatype

boolean

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

Informed Consent

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Pregnancy Absent | Childbearing Potential Contraceptive methods

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Neoadjuvant Therapy

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

Medical problem Uncontrolled

Datatype

boolean

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

Communicable Disease | Chronic infectious disease

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C3887504
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Similar models

Eligibility Breast Cancer NCT01378533

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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