ID

14827

Beschrijving

Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12; ODM derived from: https://clinicaltrials.gov/show/NCT00194753

Link

https://clinicaltrials.gov/show/NCT00194753

Trefwoorden

Versies (2)
  1. 01-05-16 01-05-16 -
  2. 02-05-16 02-05-16 - Julian Varghese
Geüploaded op

1 mei 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Breast Neoplasm NCT00194753

Engels

Eligibility Breast Neoplasm NCT00194753

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (this regimen is not intended for neoadjuvant treatment.)
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C1521996
the attending physician must judge the patient to be an appropriate candidate for adriamycin based adjuvant chemotherapy. appropriate candidates generally include those with stage ii or iii breast cancer. the individual attending physician, however, should make the decision.
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0085752
tumor her-2/neu expression must be determined prior to study enrollment. assessment may be by fluorescence in situ hybridization (fish) assay or by immunocytochemistry (icc). if determination is "intermediate" by immunocytochemistry, fish must be performed. protocol therapy is determined by her-2/neu result.
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C1512413
patient must be at least 18.
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the patient 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

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
pre-study hematologic values required for entry onto trial are: wbc greater than= 4,000/mm3, anc greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (iuln)) or hepatic dysfunction (C1278039 greater than iuln; transaminases greater than 2.5 x iuln) are not eligible.
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient has been disease free for 5 years.
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C1705847
patients with clinically apparent cardiac disease, or history of same, are not eligible. patients who are > 60 years of age or who have a history of hypertension must have a muga prior to enrollment. lvef must be normal.
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0428772
patients who have received prior chemotherapy or radiotherapy are not eligible.
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
patients who are pregnant or breastfeeding are not eligible. women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with active infection are not eligible.
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
patients who are known to be infected with hiv, or hepatitis c are not eligible. testing is not required unless there is a high index of clinical suspicion.
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
patients suffering from psychiatric impairment are not eligible.
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1]
C0846574
patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1]
C0041041
UMLS CUI [2]
C0038760
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Similar models

Eligibility Breast Neoplasm NCT00194753

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (this regimen is not intended for neoadjuvant treatment.)
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1521996 (UMLS CUI [1,4])
ID.2
Item
the attending physician must judge the patient to be an appropriate candidate for adriamycin based adjuvant chemotherapy. appropriate candidates generally include those with stage ii or iii breast cancer. the individual attending physician, however, should make the decision.
boolean
C0085533 (UMLS CUI [1,1])
C0085752 (UMLS CUI [1,2])
ID.3
Item
tumor her-2/neu expression must be determined prior to study enrollment. assessment may be by fluorescence in situ hybridization (fish) assay or by immunocytochemistry (icc). if determination is "intermediate" by immunocytochemistry, fish must be performed. protocol therapy is determined by her-2/neu result.
boolean
C1512413 (UMLS CUI [1])
ID.4
Item
patient must be at least 18.
boolean
C0001779 (UMLS CUI [1])
ID.5
Item
the patient 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])
ID.6
Item
pre-study hematologic values required for entry onto trial are: wbc greater than= 4,000/mm3, anc greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (iuln)) or hepatic dysfunction (C1278039 greater than iuln; transaminases greater than 2.5 x iuln) are not eligible.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
ID.8
Item
except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient has been disease free for 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
ID.9
Item
patients with clinically apparent cardiac disease, or history of same, are not eligible. patients who are > 60 years of age or who have a history of hypertension must have a muga prior to enrollment. lvef must be normal.
boolean
C0018799 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
ID.10
Item
patients who have received prior chemotherapy or radiotherapy are not eligible.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
ID.11
Item
patients who are pregnant or breastfeeding are not eligible. women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
ID.12
Item
patients with active infection are not eligible.
boolean
C0009450 (UMLS CUI [1])
ID.13
Item
patients who are known to be infected with hiv, or hepatitis c are not eligible. testing is not required unless there is a high index of clinical suspicion.
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
ID.14
Item
patients suffering from psychiatric impairment are not eligible.
boolean
C0846574 (UMLS CUI [1])
ID.15
Item
patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.
boolean
C0041041 (UMLS CUI [1])
C0038760 (UMLS CUI [2])
Terug naar het begin van de pagina 

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