ID

19559

Beschrijving

Neoadjuvant Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00254592

Link

https://clinicaltrials.gov/show/NCT00254592

Trefwoorden

Versies (1)
  1. 10-01-17 10-01-17 -
Geüploaded op

10 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00254592

Engels

Eligibility Breast Cancer NCT00254592

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. histologic confirmation shall be by either core needle biopsy or incisional biopsy. punch biopsy is allowed if invasive breast cancer is documented.
Beschrijving

Gender | Breast Carcinoma size | lymph node positive | Core needle biopsy | Incisional biopsy | Invasive carcinoma of breast Punch biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0746319
UMLS CUI [4]
C1318309
UMLS CUI [5]
C0184922
UMLS CUI [6,1]
C0853879
UMLS CUI [6,2]
C0184924
patients must meet one of the criteria defined below (indicate one):
Beschrijving

Clinical Trial Eligibility Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
1. selected stage iib (t3, n0, m0) or iiia (t3, n1-2, m0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.
Beschrijving

Disease unresectable TNM clinical staging | Indication Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0600558
2. stage iiib (t4, any n, m0) or (any t, n3, m0) disease.
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
Beschrijving

Malignant Neoplasms Assessment Physical Examination | Malignant Neoplasms Assessment Chest X-ray | Malignant Neoplasms Assessment X-ray | Malignant Neoplasms Assessment Scanning

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0039985
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0034571
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1516048
UMLS CUI [4,3]
C0441633
all patients must have a multiple gated acquisition (muga) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (lvef) percentage must be greater than the institutional lower limit of normal.
Beschrijving

Multiple gated acquisition scanning | Echocardiography | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0521317
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0428772
patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (sgot) or serum glutamate pyruvate transaminase (sgpt) ≤ 2x the institutional upper limit of normal. these tests must have been performed within 90 days prior to registration.
Beschrijving

Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
patients must have an absolute neutrophil count (anc) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. these tests must have been performed within 90 days prior to registration.
Beschrijving

Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
patients must have a performance status of 0-2 by zubrod criteria
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
in calculating days of tests and measurements, the day a test or measurement is done is considered day 0. therefore, if a test is done on a monday, the monday four weeks later would be considered day 28. this allows for efficient patient scheduling without exceeding the guidelines. if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
Beschrijving

Schedules, Patient | Tests | Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0030703
UMLS CUI [2]
C0392366
UMLS CUI [3]
C0242485
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible.
Beschrijving

Congestive heart failure | Angina Pectoris

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. a urine pregnancy test is required for women of childbearing potential.
Beschrijving

Pregnancy | Breast Feeding | Gender Fertility Contraceptive methods | Childbearing Potential Urine pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0015895
UMLS CUI [3,3]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430056
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Similar models

Eligibility Breast Cancer NCT00254592

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma size | lymph node positive | Core needle biopsy | Incisional biopsy | Invasive carcinoma of breast Punch biopsy
Item
patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. histologic confirmation shall be by either core needle biopsy or incisional biopsy. punch biopsy is allowed if invasive breast cancer is documented.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0746319 (UMLS CUI [3])
C1318309 (UMLS CUI [4])
C0184922 (UMLS CUI [5])
C0853879 (UMLS CUI [6,1])
C0184924 (UMLS CUI [6,2])
Clinical Trial Eligibility Criteria
Item
patients must meet one of the criteria defined below (indicate one):
boolean
C1516637 (UMLS CUI [1])
Disease unresectable TNM clinical staging | Indication Neoadjuvant Therapy
Item
1. selected stage iib (t3, n0, m0) or iiia (t3, n1-2, m0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
TNM clinical staging
Item
2. stage iiib (t4, any n, m0) or (any t, n3, m0) disease.
boolean
C3258246 (UMLS CUI [1])
Malignant Neoplasms Assessment Physical Examination | Malignant Neoplasms Assessment Chest X-ray | Malignant Neoplasms Assessment X-ray | Malignant Neoplasms Assessment Scanning
Item
physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
boolean
C0006826 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0039985 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
C0441633 (UMLS CUI [4,3])
Multiple gated acquisition scanning | Echocardiography | Left ventricular ejection fraction
Item
all patients must have a multiple gated acquisition (muga) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (lvef) percentage must be greater than the institutional lower limit of normal.
boolean
C0521317 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (sgot) or serum glutamate pyruvate transaminase (sgpt) ≤ 2x the institutional upper limit of normal. these tests must have been performed within 90 days prior to registration.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absolute neutrophil count | Platelet Count measurement
Item
patients must have an absolute neutrophil count (anc) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. these tests must have been performed within 90 days prior to registration.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Zubrod Performance Status
Item
patients must have a performance status of 0-2 by zubrod criteria
boolean
C3714786 (UMLS CUI [1])
Schedules, Patient | Tests | Measurement
Item
in calculating days of tests and measurements, the day a test or measurement is done is considered day 0. therefore, if a test is done on a monday, the monday four weeks later would be considered day 28. this allows for efficient patient scheduling without exceeding the guidelines. if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
boolean
C0030703 (UMLS CUI [1])
C0392366 (UMLS CUI [2])
C0242485 (UMLS CUI [3])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congestive heart failure | Angina Pectoris
Item
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible.
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Fertility Contraceptive methods | Childbearing Potential Urine pregnancy test
Item
pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. a urine pregnancy test is required for women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0015895 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430056 (UMLS CUI [4,2])
Terug naar het begin van de pagina 

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