ID

26060

Beskrivning

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00542191

Länk

https://clinicaltrials.gov/show/NCT00542191

Nyckelord

Versioner (1)
  1. 2017-10-05 2017-10-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 oktober 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT00542191

Engelsk

Eligibility Breast Cancer NCT00542191

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with estrogen receptor (er), progesterone receptor (pr),and her2 negative invasive breast cancer confirmed on core biopsy.(note: her2 negative by fish preferred; her2 0 or 1+ by ihc acceptable)
Beskrivning

Gender | Triple Negative Breast Neoplasms Core biopsy | HER2 negative FISH | HER2 negative Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3539878
UMLS CUI [2,2]
C1318309
UMLS CUI [3,1]
C4087376
UMLS CUI [3,2]
C0162789
UMLS CUI [4,1]
C4087376
UMLS CUI [4,2]
C0021044
primary tumor size 2cm or greater by physical exam or radiographic measurements.(note: locally advanced t4 or inflammatory breast cancer is eligible.)
Beskrivning

Primary tumor size Physical Examination | Primary tumor size Radiography | TNM clinical staging Advanced Locally | Inflammatory Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1302656
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1302656
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4]
C0278601
assessment of pre-treatment axillary lymph nodal status (note: fna biopsy if palpable or sentinel lymph node biopsy (slnb) if not palpable preferred; clinical exam acceptable.)
Beskrivning

Assessment Axillary lymph node Status pre treatment | Lymph node palpable Fine needle aspiration biopsy | Lymph node palpable Absent Sentinel Lymph Node Biopsy | Clinical examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C2709094
UMLS CUI [2,1]
C1112395
UMLS CUI [2,2]
C1510483
UMLS CUI [3,1]
C1112395
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0796693
UMLS CUI [4]
C1456356
absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
Beskrivning

Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
normal myocardial left ventricular function
Beskrivning

Left ventricular ejection fraction Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
serum creatinine < 2.0 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin and ast < 3x upper limits normal
Beskrivning

Serum total bilirubin measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent or metastatic breast cancer findings (note: if oncologically felt to be a second breast primary, patient eligible for this protocol)
Beskrivning

Breast cancer recurrent | Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2]
C0346993
another active cancer present
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
medical contraindications to chemotherapy or surgery
Beskrivning

Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
first trimester pregnancy
Beskrivning

Pregnancy Trimester, First

Datatyp

boolean

Alias
UMLS CUI [1]
C0032979
breast feeding
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT00542191

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Triple Negative Breast Neoplasms Core biopsy | HER2 negative FISH | HER2 negative Immunohistochemistry
Item
women with estrogen receptor (er), progesterone receptor (pr),and her2 negative invasive breast cancer confirmed on core biopsy.(note: her2 negative by fish preferred; her2 0 or 1+ by ihc acceptable)
boolean
C0079399 (UMLS CUI [1])
C3539878 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
C4087376 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C4087376 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
Primary tumor size Physical Examination | Primary tumor size Radiography | TNM clinical staging Advanced Locally | Inflammatory Breast Carcinoma
Item
primary tumor size 2cm or greater by physical exam or radiographic measurements.(note: locally advanced t4 or inflammatory breast cancer is eligible.)
boolean
C1302656 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1302656 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0278601 (UMLS CUI [4])
Assessment Axillary lymph node Status pre treatment | Lymph node palpable Fine needle aspiration biopsy | Lymph node palpable Absent Sentinel Lymph Node Biopsy | Clinical examination
Item
assessment of pre-treatment axillary lymph nodal status (note: fna biopsy if palpable or sentinel lymph node biopsy (slnb) if not palpable preferred; clinical exam acceptable.)
boolean
C1516048 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C2709094 (UMLS CUI [1,4])
C1112395 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C1112395 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0796693 (UMLS CUI [3,3])
C1456356 (UMLS CUI [4])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Left ventricular ejection fraction Normal
Item
normal myocardial left ventricular function
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
total bilirubin and ast < 3x upper limits normal
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent | Secondary malignant neoplasm of female breast
Item
recurrent or metastatic breast cancer findings (note: if oncologically felt to be a second breast primary, patient eligible for this protocol)
boolean
C0278493 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Malignant Neoplasms
Item
another active cancer present
boolean
C0006826 (UMLS CUI [1])
Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures
Item
medical contraindications to chemotherapy or surgery
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Pregnancy Trimester, First
Item
first trimester pregnancy
boolean
C0032979 (UMLS CUI [1])
Breast Feeding
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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