ID

16279

Beschreibung

Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00201773

Link

https://clinicaltrials.gov/show/NCT00201773

Stichworte

Versionen (1)
  1. 09.07.16 09.07.16 -
Hochgeladen am

9. Juli 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00201773

Englisch

Eligibility Breast Cancer NCT00201773

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be female with histologically confirmed breast cancer
Beschreibung

Gender | Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
stage ii-iv disease
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
er and/or pr positive
Beschreibung

Estrogen receptor positive | progesterone receptor positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.
Beschreibung

Malignant Neoplasm Presence following Core needle biopsy | Physical Examination | Evaluation Radiographic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0231290
UMLS CUI [1,4]
C1318309
UMLS CUI [2]
C0031809
UMLS CUI [3,1]
C0220825
UMLS CUI [3,2]
C0444708
postmenopausal
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
no prior treatment for current breast cancer. no other active malignancy is allowed.adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. biphosphonates and palliative radiation for bone metastasis is permitted while on study.
Beschreibung

Prior Therapy Breast Carcinoma | Therapeutic procedure Basal cell carcinoma | Therapeutic procedure Squamous cell carcinoma of skin | Therapeutic procedure Carcinoma in situ of uterine cervix | Therapeutic procedure Malignant Neoplasms | Disease Free of | Diphosphonates Secondary malignant neoplasm of bone | Palliative Radiation Therapy Secondary malignant neoplasm of bone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0006826
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0332296
UMLS CUI [7,1]
C0012544
UMLS CUI [7,2]
C0153690
UMLS CUI [8,1]
C3898008
UMLS CUI [8,2]
C0153690
hormone replacement therapy must be discontinued. it is not permitted during the time on study.
Beschreibung

Hormone replacement therapy Discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C1444662
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of aspirin or nsaid induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.
Beschreibung

Asthma, Aspirin-Induced | Urticaria | Allergic Reaction | Hypersensitivity Sulfonamides | Requirement Therapeutic procedure Emergency room | Requirement Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C1319853
UMLS CUI [2]
C0042109
UMLS CUI [3]
C1527304
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0038760
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C0562508
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0019993
history of myocardial infarction or other thrombotic events.
Beschreibung

Myocardial Infarction | Event Thrombotic

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0087086
inflammatory breast cancer (edema or ulceration of the skin of the breast).
Beschreibung

Inflammatory Breast Carcinoma | Edema of breast | Ulceration of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C0235649
UMLS CUI [3]
C0425793
significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).
Beschreibung

Renal dysfunction Significant | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0201976
significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or ast, alt > 3 x upper limit of normal)
Beschreibung

Liver Dysfunction Significant | Serum bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0428441
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
anc <1.5, platelets <100,000 k/ul, and hemoglobin < 9 g/dl.
Beschreibung

Absolute neutrophil count | Blood Platelets | Hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
use of other cox-2 inhibitors such as rofecoxib (vioxx®, aspirin, trisalicylate (trilisate®), is not permitted during the time on study. no washout period is required. baby aspirin, 81 mg po daily, is permitted.
Beschreibung

Cyclooxygenase 2 Inhibitors | rofecoxib | Vioxx | Aspirin | Trisalicyclate | Trilisate | Washout Period | Aspirin Low Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C1257954
UMLS CUI [2]
C0762662
UMLS CUI [3]
C0876768
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0719064
UMLS CUI [6]
C0878190
UMLS CUI [7]
C1710661
UMLS CUI [8]
C2608320
use of nsaid's such as ibuprofen (advil® or motrin®), naproxyn (aleve® naprosyn®, or anaprox®), etodolac (lodine®), oxaprozin (daypro®), difusanil (dolobid®), nabumetone (relafin®), or tolmetin (tolectin®) is not permitted during the time on study.
Beschreibung

Anti-Inflammatory Agents, Non-Steroidal | Ibuprofen | Advil | Motrin | Aleve | Naprosyn | Anaprox | Etodolac | Lodine | oxaprozin | Daypro | Dolobid | nabumetone | Tolmetin | Tolectin

Datentyp

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0020740
UMLS CUI [3]
C0593507
UMLS CUI [4]
C0699203
UMLS CUI [5]
C0718343
UMLS CUI [6]
C0700017
UMLS CUI [7]
C0699095
UMLS CUI [8]
C0059865
UMLS CUI [9]
C0700001
UMLS CUI [10]
C0069739
UMLS CUI [11]
C0603695
UMLS CUI [12]
C0699201
UMLS CUI [13]
C0068334
UMLS CUI [14]
C0040377
UMLS CUI [15]
C0733360
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00201773

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma
Item
must be female with histologically confirmed breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
TNM clinical staging
Item
stage ii-iv disease
boolean
C3258246 (UMLS CUI [1])
Estrogen receptor positive | progesterone receptor positive
Item
er and/or pr positive
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasm Presence following Core needle biopsy | Physical Examination | Evaluation Radiographic
Item
tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.
boolean
C0006826 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C1318309 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0220825 (UMLS CUI [3,1])
C0444708 (UMLS CUI [3,2])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Prior Therapy Breast Carcinoma | Therapeutic procedure Basal cell carcinoma | Therapeutic procedure Squamous cell carcinoma of skin | Therapeutic procedure Carcinoma in situ of uterine cervix | Therapeutic procedure Malignant Neoplasms | Disease Free of | Diphosphonates Secondary malignant neoplasm of bone | Palliative Radiation Therapy Secondary malignant neoplasm of bone
Item
no prior treatment for current breast cancer. no other active malignancy is allowed.adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. biphosphonates and palliative radiation for bone metastasis is permitted while on study.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
C0012544 (UMLS CUI [7,1])
C0153690 (UMLS CUI [7,2])
C3898008 (UMLS CUI [8,1])
C0153690 (UMLS CUI [8,2])
Hormone replacement therapy Discontinued
Item
hormone replacement therapy must be discontinued. it is not permitted during the time on study.
boolean
C0282402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Asthma, Aspirin-Induced | Urticaria | Allergic Reaction | Hypersensitivity Sulfonamides | Requirement Therapeutic procedure Emergency room | Requirement Hospitalization
Item
known history of aspirin or nsaid induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.
boolean
C1319853 (UMLS CUI [1])
C0042109 (UMLS CUI [2])
C1527304 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0038760 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C0562508 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0019993 (UMLS CUI [6,2])
Myocardial Infarction | Event Thrombotic
Item
history of myocardial infarction or other thrombotic events.
boolean
C0027051 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C0087086 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma | Edema of breast | Ulceration of breast
Item
inflammatory breast cancer (edema or ulceration of the skin of the breast).
boolean
C0278601 (UMLS CUI [1])
C0235649 (UMLS CUI [2])
C0425793 (UMLS CUI [3])
Renal dysfunction Significant | Creatinine measurement, serum
Item
significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).
boolean
C3279454 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Liver Dysfunction Significant | Serum bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or ast, alt > 3 x upper limit of normal)
boolean
C0086565 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0428441 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
anc <1.5, platelets <100,000 k/ul, and hemoglobin < 9 g/dl.
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Cyclooxygenase 2 Inhibitors | rofecoxib | Vioxx | Aspirin | Trisalicyclate | Trilisate | Washout Period | Aspirin Low Dose
Item
use of other cox-2 inhibitors such as rofecoxib (vioxx®, aspirin, trisalicylate (trilisate®), is not permitted during the time on study. no washout period is required. baby aspirin, 81 mg po daily, is permitted.
boolean
C1257954 (UMLS CUI [1])
C0762662 (UMLS CUI [2])
C0876768 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0719064 (UMLS CUI [5])
C0878190 (UMLS CUI [6])
C1710661 (UMLS CUI [7])
C2608320 (UMLS CUI [8])
Anti-Inflammatory Agents, Non-Steroidal | Ibuprofen | Advil | Motrin | Aleve | Naprosyn | Anaprox | Etodolac | Lodine | oxaprozin | Daypro | Dolobid | nabumetone | Tolmetin | Tolectin
Item
use of nsaid's such as ibuprofen (advil® or motrin®), naproxyn (aleve® naprosyn®, or anaprox®), etodolac (lodine®), oxaprozin (daypro®), difusanil (dolobid®), nabumetone (relafin®), or tolmetin (tolectin®) is not permitted during the time on study.
boolean
C0003211 (UMLS CUI [1])
C0020740 (UMLS CUI [2])
C0593507 (UMLS CUI [3])
C0699203 (UMLS CUI [4])
C0718343 (UMLS CUI [5])
C0700017 (UMLS CUI [6])
C0699095 (UMLS CUI [7])
C0059865 (UMLS CUI [8])
C0700001 (UMLS CUI [9])
C0069739 (UMLS CUI [10])
C0603695 (UMLS CUI [11])
C0699201 (UMLS CUI [12])
C0068334 (UMLS CUI [13])
C0040377 (UMLS CUI [14])
C0733360 (UMLS CUI [15])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video