ID

16250

Beschreibung

Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin; ODM derived from: https://clinicaltrials.gov/show/NCT00162812

Link

https://clinicaltrials.gov/show/NCT00162812

Stichworte

Versionen (1)
  1. 07.07.16 07.07.16 -
Hochgeladen am

7. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00162812

Englisch

Eligibility Breast Cancer NCT00162812

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
Beschreibung

Breast Carcinoma Operable | Locally advanced breast cancer | Inflammatory Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205188
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0278601
2. age less than 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. female patient
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
4. tumor size 2 cm at ultrasound examination.
Beschreibung

Tumor size | Ultrasound examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0948501
5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
Beschreibung

Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells

Datentyp

boolean

Alias
UMLS CUI [1]
C2584629
UMLS CUI [2]
C0021044
UMLS CUI [3]
C0439178
6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
Beschreibung

Multifocal breast carcinoma | Multicentric Breast Carcinoma | Foci Estrogen receptor negative

Datentyp

boolean

Alias
UMLS CUI [1]
C2986662
UMLS CUI [2]
C2986664
UMLS CUI [3,1]
C0205234
UMLS CUI [3,2]
C0279756
7. fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo ii alpha gene and protein, her-2 gene, p-53 gene, oligonucleotides microarrays).
Beschreibung

primary tumor Fixed Specimen | primary tumor Frozen Specimen | Epirubicin | Biological Markers Evaluation | TOP2A gene | DNA topoisomerase II alpha | ERBB2 gene | TP53 gene | Oligonucleotide Arrays

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2827483
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1548793
UMLS CUI [3]
C0014582
UMLS CUI [4,1]
C0005516
UMLS CUI [4,2]
C1261322
UMLS CUI [5]
C1336657
UMLS CUI [6]
C0256022
UMLS CUI [7]
C0242957
UMLS CUI [8]
C0079419
UMLS CUI [9]
C0600597
8. written informed consent before study registration.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
9. performance status 0 or 1 (ecog scale)
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
10. normal cbc, hepatic and renal functions
Beschreibung

Complete Blood Count | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0009555
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
11. normal left ventricular ejection fraction by echocardiography or muga scan
Beschreibung

Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
12. negative pregnancy test for all women of childbearing potential. patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. metastatic breast cancer
Beschreibung

Carcinoma breast stage IV

Datentyp

boolean

Alias
UMLS CUI [1]
C0278488
2. serious medical conditions like:
Beschreibung

medical condition Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
Beschreibung

Congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
2. history of significant neurologic or psychiatric disorders
Beschreibung

nervous system disorder Significant | Mental disorders Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
3. active uncontrolled infection
Beschreibung

Communicable Diseases Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
4. active peptic ulcer, unstable diabetes mellitus
Beschreibung

Peptic Ulcer | Brittle diabetes

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0342302
3. concomitant contralateral invasive breast cancer
Beschreibung

Contralateral breast cancer Invasive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096616
UMLS CUI [1,2]
C0205281
4. concurrent treatment with hormonal replacement therapy
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
5. concurrent treatment with any other anti-cancer therapy
Beschreibung

cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
6. previous treatment with anthracyclines for breast cancer
Beschreibung

prior anthracycline therapy Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278941
UMLS CUI [1,2]
C0678222
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Ähnliche Modelle

Eligibility Breast Cancer NCT00162812

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Operable | Locally advanced breast cancer | Inflammatory Breast Carcinoma
Item
1. histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Age
Item
2. age less than 70 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
3. female patient
boolean
C0079399 (UMLS CUI [1])
Tumor size | Ultrasound examination
Item
4. tumor size 2 cm at ultrasound examination.
boolean
C0475440 (UMLS CUI [1])
C0948501 (UMLS CUI [2])
Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells
Item
5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
boolean
C2584629 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0439178 (UMLS CUI [3])
Multifocal breast carcinoma | Multicentric Breast Carcinoma | Foci Estrogen receptor negative
Item
6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
boolean
C2986662 (UMLS CUI [1])
C2986664 (UMLS CUI [2])
C0205234 (UMLS CUI [3,1])
C0279756 (UMLS CUI [3,2])
primary tumor Fixed Specimen | primary tumor Frozen Specimen | Epirubicin | Biological Markers Evaluation | TOP2A gene | DNA topoisomerase II alpha | ERBB2 gene | TP53 gene | Oligonucleotide Arrays
Item
7. fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo ii alpha gene and protein, her-2 gene, p-53 gene, oligonucleotides microarrays).
boolean
C0677930 (UMLS CUI [1,1])
C2827483 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1548793 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3])
C0005516 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
C1336657 (UMLS CUI [5])
C0256022 (UMLS CUI [6])
C0242957 (UMLS CUI [7])
C0079419 (UMLS CUI [8])
C0600597 (UMLS CUI [9])
Informed consent
Item
8. written informed consent before study registration.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
9. performance status 0 or 1 (ecog scale)
boolean
C1520224 (UMLS CUI [1])
Complete Blood Count | Liver function | Renal function
Item
10. normal cbc, hepatic and renal functions
boolean
C0009555 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
11. normal left ventricular ejection fraction by echocardiography or muga scan
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Hormonal contraception
Item
12. negative pregnancy test for all women of childbearing potential. patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Carcinoma breast stage IV
Item
1. metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
medical condition Serious
Item
2. serious medical conditions like:
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
Item
1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
nervous system disorder Significant | Mental disorders Significant
Item
2. history of significant neurologic or psychiatric disorders
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Communicable Diseases Uncontrolled
Item
3. active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Peptic Ulcer | Brittle diabetes
Item
4. active peptic ulcer, unstable diabetes mellitus
boolean
C0030920 (UMLS CUI [1])
C0342302 (UMLS CUI [2])
Contralateral breast cancer Invasive
Item
3. concomitant contralateral invasive breast cancer
boolean
C1096616 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Hormone replacement therapy
Item
4. concurrent treatment with hormonal replacement therapy
boolean
C0282402 (UMLS CUI [1])
cancer treatment
Item
5. concurrent treatment with any other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])
prior anthracycline therapy Breast Carcinoma
Item
6. previous treatment with anthracyclines for breast cancer
boolean
C0278941 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
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