ID

38099

Beschreibung

Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01622361

Link

https://clinicaltrials.gov/show/NCT01622361

Stichworte

Versionen (1)
  1. 17.09.19 17.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01622361

Englisch

Eligibility Breast Cancer NCT01622361

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
Beschreibung

Invasive carcinoma of breast Appropriate Neoadjuvant Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0600558
2. pathologically proven lymph node positive tumor(fnab or core biopsy)
Beschreibung

Neoplasm Lymph node positive Fine needle aspiration biopsy | Neoplasm Lymph node positive Core needle biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0746319
UMLS CUI [1,3]
C1510483
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0746319
UMLS CUI [2,3]
C1318309
3. tumor must be er positive(eligible patients include allred score 5 and more, modified allred 4 and more) and her-2 negative(ihc score is 0-1+; if ihc score is 2+, the result of fish or sish is negative)
Beschreibung

Neoplasm Estrogen receptor positive Allred score | Neoplasm HER2 Negative Immunohistochemistry | Neoplasm HER2 Negative Fluorescent in Situ Hybridization | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C2919519
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C2348908
UMLS CUI [3,3]
C0162789
UMLS CUI [4]
C3846158
4. premenopausal women
Beschreibung

Gender | Premenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232969
premenopausal status as defined by :
Beschreibung

Premenopausal state Definition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C1704788
last menses within 6 month of randomization or
Beschreibung

Menstruation Last Recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0332185
for patients who have had a unilateral oophorectomy, e2 ≥ 20pg/ml and fsh < 30miu/ml within 4 weeks of randomization
Beschreibung

Unilateral oophorectomy | Estradiol measurement | Follicle stimulating hormone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0041687
UMLS CUI [2]
C0337434
UMLS CUI [3]
C0202022
5. over 20 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. pre-treatment haematology and biochemistry values within acceptable limits :
Beschreibung

pre treatment Hematology | pre treatment Biochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C0200627
UMLS CUI [2,1]
C2709094
UMLS CUI [2,2]
C0428132
anc ≥ 1.5 × 109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
hb > 9g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
platelets ≥ 100 × 109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
ast/alt ≤ 1.5 × uln(upper limit of normal)
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alp ≤ 1.5 × uln
Beschreibung

Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201850
serum bilirubin ≤ 1.5 × uln
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine ≤ 1.5 × uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
7. ecog ps of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. no concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
Beschreibung

Exclusion Criteria | Comorbidity Preventing Treatment completion | Comorbidity Preventing Follow-up | Mental problem Preventing Treatment completion | Mental problem Preventing Follow-up | Geographic Factors Preventing Treatment completion | Geographic Factors Preventing Follow-up

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0580352
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C0848067
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0580352
UMLS CUI [5,1]
C0848067
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C0017444
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0580352
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C3274571
9. before any study-specific procedures, the appropriate written informed consent must be obtained
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inflammatory breast cancer
Beschreibung

Inflammatory Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
2. inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
Beschreibung

Disease Inoperable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205187
3. known severe hypersensitivity to gnrha treatment
Beschreibung

Severe allergy GNRH-A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C2012324
4. bilateral invasive breast cancer
Beschreibung

Invasive carcinoma of breast Bilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
5. other serious illness or medical condition:
Beschreibung

Illness Serious | Other medical condition Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
Beschreibung

Congestive heart failure | Angina, Unstable | Myocardial Infarction | Uncontrolled hypertension | High risk of Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0332167
UMLS CUI [5,2]
C0003811
UMLS CUI [5,3]
C0205318
history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
Beschreibung

Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia | Seizures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0036572
active uncontrolled infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
6. hrt within 4 weeks of starting treatment
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
7. definite contra-indications for the use of corticosteroids.
Beschreibung

Medical contraindication Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
8. last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection)
Beschreibung

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Excision only

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728940
UMLS CUI [4,3]
C0205171
9. systemic metastatic (tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
Beschreibung

Neoplasm Metastasis Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205373
10. pregnant or breastfeeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
Beschreibung

Adrenal Cortex Hormones Oral chronic | Exception Low-Dose Treatment | Exception Methylprednisolone Dose | Exception Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1708745
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025815
UMLS CUI [3,3]
C0178602
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0205163
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Ähnliche Modelle

Eligibility Breast Cancer NCT01622361

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Appropriate Neoadjuvant Therapy
Item
1. histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
boolean
C0853879 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
Neoplasm Lymph node positive Fine needle aspiration biopsy | Neoplasm Lymph node positive Core needle biopsy
Item
2. pathologically proven lymph node positive tumor(fnab or core biopsy)
boolean
C0027651 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
C1510483 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0746319 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
Neoplasm Estrogen receptor positive Allred score | Neoplasm HER2 Negative Immunohistochemistry | Neoplasm HER2 Negative Fluorescent in Situ Hybridization | Other Coding
Item
3. tumor must be er positive(eligible patients include allred score 5 and more, modified allred 4 and more) and her-2 negative(ihc score is 0-1+; if ihc score is 2+, the result of fish or sish is negative)
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C2919519 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C3846158 (UMLS CUI [4])
Gender | Premenopausal state
Item
4. premenopausal women
boolean
C0079399 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
Premenopausal state Definition
Item
premenopausal status as defined by :
boolean
C0232969 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
Menstruation Last Recently
Item
last menses within 6 month of randomization or
boolean
C0025344 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Unilateral oophorectomy | Estradiol measurement | Follicle stimulating hormone measurement
Item
for patients who have had a unilateral oophorectomy, e2 ≥ 20pg/ml and fsh < 30miu/ml within 4 weeks of randomization
boolean
C0041687 (UMLS CUI [1])
C0337434 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
Age
Item
5. over 20 years old
boolean
C0001779 (UMLS CUI [1])
pre treatment Hematology | pre treatment Biochemistry
Item
6. pre-treatment haematology and biochemistry values within acceptable limits :
boolean
C2709094 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2,1])
C0428132 (UMLS CUI [2,2])
Absolute neutrophil count
Item
anc ≥ 1.5 × 109/l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hb > 9g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 × 109/l
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt ≤ 1.5 × uln(upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
alp ≤ 1.5 × uln
boolean
C0201850 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin ≤ 1.5 × uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 × uln
boolean
C0201976 (UMLS CUI [1])
ECOG performance status
Item
7. ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria | Comorbidity Preventing Treatment completion | Comorbidity Preventing Follow-up | Mental problem Preventing Treatment completion | Mental problem Preventing Follow-up | Geographic Factors Preventing Treatment completion | Geographic Factors Preventing Follow-up
Item
8. no concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
boolean
C0680251 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0848067 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
C0848067 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C0017444 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0580352 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C3274571 (UMLS CUI [7,3])
Informed Consent
Item
9. before any study-specific procedures, the appropriate written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory Breast Carcinoma
Item
1. inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Disease Inoperable
Item
2. inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
boolean
C0012634 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Severe allergy GNRH-A
Item
3. known severe hypersensitivity to gnrha treatment
boolean
C2945656 (UMLS CUI [1,1])
C2012324 (UMLS CUI [1,2])
Invasive carcinoma of breast Bilateral
Item
4. bilateral invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Illness Serious | Other medical condition Serious
Item
5. other serious illness or medical condition:
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction | Uncontrolled hypertension | High risk of Cardiac Arrhythmia Uncontrolled
Item
congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0332167 (UMLS CUI [5,1])
C0003811 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia | Seizures
Item
history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hormone replacement therapy
Item
6. hrt within 4 weeks of starting treatment
boolean
C0282402 (UMLS CUI [1])
Medical contraindication Adrenal Cortex Hormones
Item
7. definite contra-indications for the use of corticosteroids.
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Excision only
Item
8. last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Neoplasm Metastasis Systemic
Item
9. systemic metastatic (tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
boolean
C0027627 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
10. pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adrenal Cortex Hormones Oral chronic | Exception Low-Dose Treatment | Exception Methylprednisolone Dose | Exception Equivalent
Item
11. chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1708745 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
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