ID

27232

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01104935

Keywords

versioni (1)
  1. 03/11/17 03/11/17 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

3 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Breast Cancer NCT01104935

Inglese

Eligibility Breast Cancer NCT01104935

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Invasive carcinoma of breast | Curative Surgery Breast Carcinoma Primary

Tipo di dati

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
Descrizione

TNM Breast tumor staging | Tumor size

Tipo di dati

boolean

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

Gender | Age

Tipo di dati

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
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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)
Descrizione

ECOG performance status

Tipo di dati

boolean

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

Organ function

Tipo di dati

boolean

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

White Blood Cell Count procedure

Tipo di dati

boolean

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

Absolute neutrophil count

Tipo di dati

boolean

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

Platelet Count measurement

Tipo di dati

boolean

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

Serum total bilirubin measurement

Tipo di dati

boolean

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

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo di dati

boolean

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

Creatinine measurement, serum

Tipo di dati

boolean

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

Alkaline phosphatase measurement

Tipo di dati

boolean

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

Hormone Therapy Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma

Tipo di dati

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)
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

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

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

Tipo di dati

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
Descrizione

AXILLARY LYMPH NODE METASTASIS Postoperative

Tipo di dati

boolean

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

Axillary lymph nodes Histology Procedure Lacking

Tipo di dati

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)
Descrizione

Breast-Conserving Surgery Positive Surgical Margin

Tipo di dati

boolean

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

Drug Allergy Preventing Planned Treatment

Tipo di dati

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
Descrizione

Heart Diseases | Cardiac complication

Tipo di dati

boolean

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

Congestive heart failure | Myocardial Infarction

Tipo di dati

boolean

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

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

Tipo di dati

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)
Descrizione

Hypertensive disease Poorly controlled | Systolic Pressure | Diastolic blood pressure

Tipo di dati

boolean

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

Poorly controlled diabetes mellitus

Tipo di dati

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)
Descrizione

Patient Visit Difficult | Deterioration Activities of Daily Living

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Patient Ineligible

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
Ritorna all'inizio della pagina

Similar models

Eligibility Breast Cancer NCT01104935

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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