Eligibility Breast Cancer NCT01622361

1 Formulários

StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01622361

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

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])

Exclusion Criteria

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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Eligibility Breast Cancer NCT01622361