ID

27232

Beschreibung

Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01104935

Link

https://clinicaltrials.gov/show/NCT01104935

Stichworte

Versionen (1)
  1. 03.11.17 03.11.17 -
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See clinicaltrials.gov

Hochgeladen am

3. November 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01104935

Englisch

Eligibility Breast Cancer NCT01104935

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
Beschreibung

Invasive carcinoma of breast | Curative Surgery Breast Carcinoma Primary

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C1511562
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0205225
2. stage: 1 (tumor size [pt] > 0.5 cm), 2a, 2b or 3a/ m0
Beschreibung

TNM Breast tumor staging | Tumor size

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2]
C0475440
3. female between 69 and 81 years old
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
4. primary region is her 2 positive: either 3+ overexpression by ihc or positive by fish
Beschreibung

HER2/Neu Positive Overexpression Immunohistochemistry | HER2/Neu Positive FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C2348909
UMLS CUI [2,2]
C0162789
5. baseline left ventricular ejection fraction (lvef) is ≥55% measured by echocardiography or muga scan within 4 weeks before registration.
Beschreibung

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
6. ps: 0-1 (ecog)
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. sufficient organ function meeting following criteria within 4 weeks before registration:
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
leukocyte ≥2500 mm3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
neutrophil ≥1500 mm3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet ≥100 000 mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
serum total bilirubin ≤2.0 x upper limit of normal (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
alt (gpt) or ast (got) ≤2.5 x uln
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
serum creatinine ≤2.0 x uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
alp ≤2.5 x uln
Beschreibung

Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201850
8. no previous endocrine therapy or chemotherapy for breast cancer
Beschreibung

Hormone Therapy Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0678222
9. signed written informed consent (appendix a)
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
Beschreibung

Multiple cancer, primary | Multiple primary cancer Synchronous | Invasive cancer Organ Other

Datentyp

boolean

Alias
UMLS CUI [1]
C0865021
UMLS CUI [2,1]
C0865021
UMLS CUI [2,2]
C0439580
UMLS CUI [3,1]
C0677898
UMLS CUI [3,2]
C0178784
UMLS CUI [3,3]
C0205394
2. postoperative histological axillary lymph node metastasis ≥4
Beschreibung

AXILLARY LYMPH NODE METASTASIS Postoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741344
UMLS CUI [1,2]
C0032790
3. axillary lymph node is not histologically evaluated
Beschreibung

Axillary lymph nodes Histology Procedure Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0344441
UMLS CUI [1,3]
C0332268
4. histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
Beschreibung

Breast-Conserving Surgery Positive Surgical Margin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C1709603
5. history of drug-related allergy which could hinder planned treatment
Beschreibung

Drug Allergy Preventing Planned Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C3641097
6. any history or complication of following cardiac disorders
Beschreibung

Heart Diseases | Cardiac complication

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0161816
history of congestive heart failure, cardiac infarction
Beschreibung

Congestive heart failure | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
Beschreibung

Complication Treatment required for | Myocardial Ischemia | Cardiac Arrhythmia | Heart valve disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0018824
7. poorly controlled hypertension (ex. systolic arterial pressure ≥180 mmhg or diastolic blood pressure ≥100 mmhg)
Beschreibung

Hypertensive disease Poorly controlled | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
8. poorly controlled diabetes
Beschreibung

Poorly controlled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0554876
9. continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (adl)
Beschreibung

Patient Visit Difficult | Deterioration Activities of Daily Living

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0332218
UMLS CUI [2,1]
C0868945
UMLS CUI [2,2]
C0001288
10. difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
Beschreibung

Mental disorders Study Subject Participation Status Difficult | Psychiatric symptom Study Subject Participation Status Difficult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332218
UMLS CUI [2,1]
C0233401
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332218
11. ineligible to the trial based on decision of an investigator
Beschreibung

Patient Ineligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
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Ähnliche Modelle

Eligibility Breast Cancer NCT01104935

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Curative Surgery Breast Carcinoma Primary
Item
1. histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
boolean
C0853879 (UMLS CUI [1])
C1511562 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
TNM Breast tumor staging | Tumor size
Item
2. stage: 1 (tumor size [pt] > 0.5 cm), 2a, 2b or 3a/ m0
boolean
C0474926 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
Gender | Age
Item
3. female between 69 and 81 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2/Neu Positive Overexpression Immunohistochemistry | HER2/Neu Positive FISH
Item
4. primary region is her 2 positive: either 3+ overexpression by ihc or positive by fish
boolean
C2348909 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
5. baseline left ventricular ejection fraction (lvef) is ≥55% measured by echocardiography or muga scan within 4 weeks before registration.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
ECOG performance status
Item
6. ps: 0-1 (ecog)
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
7. sufficient organ function meeting following criteria within 4 weeks before registration:
boolean
C0678852 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leukocyte ≥2500 mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophil ≥1500 mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet ≥100 000 mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin ≤2.0 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt (gpt) or ast (got) ≤2.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤2.0 x uln
boolean
C0201976 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alp ≤2.5 x uln
boolean
C0201850 (UMLS CUI [1])
Hormone Therapy Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma
Item
8. no previous endocrine therapy or chemotherapy for breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Informed Consent
Item
9. signed written informed consent (appendix a)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple cancer, primary | Multiple primary cancer Synchronous | Invasive cancer Organ Other
Item
1. active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
boolean
C0865021 (UMLS CUI [1])
C0865021 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C0677898 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
AXILLARY LYMPH NODE METASTASIS Postoperative
Item
2. postoperative histological axillary lymph node metastasis ≥4
boolean
C0741344 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Axillary lymph nodes Histology Procedure Lacking
Item
3. axillary lymph node is not histologically evaluated
boolean
C0729594 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Breast-Conserving Surgery Positive Surgical Margin
Item
4. histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
boolean
C0917927 (UMLS CUI [1,1])
C1709603 (UMLS CUI [1,2])
Drug Allergy Preventing Planned Treatment
Item
5. history of drug-related allergy which could hinder planned treatment
boolean
C0013182 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C3641097 (UMLS CUI [1,3])
Heart Diseases | Cardiac complication
Item
6. any history or complication of following cardiac disorders
boolean
C0018799 (UMLS CUI [1])
C0161816 (UMLS CUI [2])
Congestive heart failure | Myocardial Infarction
Item
history of congestive heart failure, cardiac infarction
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Complication Treatment required for | Myocardial Ischemia | Cardiac Arrhythmia | Heart valve disease
Item
complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
boolean
C0009566 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018824 (UMLS CUI [4])
Hypertensive disease Poorly controlled | Systolic Pressure | Diastolic blood pressure
Item
7. poorly controlled hypertension (ex. systolic arterial pressure ≥180 mmhg or diastolic blood pressure ≥100 mmhg)
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Poorly controlled diabetes mellitus
Item
8. poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
Patient Visit Difficult | Deterioration Activities of Daily Living
Item
9. continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (adl)
boolean
C1512346 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0868945 (UMLS CUI [2,1])
C0001288 (UMLS CUI [2,2])
Mental disorders Study Subject Participation Status Difficult | Psychiatric symptom Study Subject Participation Status Difficult
Item
10. difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0233401 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Patient Ineligible
Item
11. ineligible to the trial based on decision of an investigator
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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