ID

13040

Beskrivning

Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00001507

Länk

https://clinicaltrials.gov/show/NCT00001507

Nyckelord

Versioner (1)
  1. 2016-01-12 2016-01-12 -
Uppladdad den

12 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasm NCT00001507

Engelsk

Eligibility Breast Neoplasm NCT00001507

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater or equal to 18 years.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
all patients must have a histologically confirmed diagnosis of inflammatory breast carcinoma stage iii b. patients with no clinical inflammatory signs but with tumor invasion of dermal lymphatic on histology are eligible. patients with metastatic disease and inflammatory breast carcinoma are not eligible. all pathologic material must be reviewed and confirmed by the department of pathology of the treating institution prior to treatment (there will be no central pathology review).
Beskrivning

breast cancer, inflammatory / invasive, matastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C1300072
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0205281
UMLS CUI [4]
C0027627
patients may be untreated or may have received prior induction chemotherapy outside the nci. if patients received prior induction chemotherapy, they may not have been unresponsive to it. they may have received chemotherapy either before (neo-adjuvant setting) or after local surgery (adjuvant setting).
Beskrivning

prior chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0521982
karnofsky performance status of greater than 70% (ecog 0 or 1).
Beskrivning

karnofsky performance, ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
ejection fraction by muga or 2-d echocardiogram within institution normal limits.
Beskrivning

ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
creatinine clearance of greater than 60 cc/mm.
Beskrivning

creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
ast and alt less than 3 times the upper limit of normal.
Beskrivning

ast and alt

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
bilirubin less than 1.5 (except in cases of gilbert's disease).
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
anc greater than l000/mm(3).
Beskrivning

anc

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count greater than 90,000/mm(3).
Beskrivning

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
dlco greater than 50%.
Beskrivning

dlco

Datatyp

boolean

Alias
UMLS CUI [1]
C1516251
no history of medical or psychiatric disease which would preclude safe treatment in the view of the principal investigator.
Beskrivning

Compliance behaviour limited by comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
no history of abnormal bleeding tendency or predisposition to repeated infections.
Beskrivning

coagulation disorders, repeated infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0239998
patients must be able to give informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with inflammatory breast cancer but with metastatic disease.
Beskrivning

inflammatory breast cancer but with metastatic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C0027627
any patient may be excluded from this study at the discretion of the principal investigator if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
Beskrivning

participation representing an unacceptable medical or psychiatric risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
any patient with a need for chronic steroids or anticoagulation will be ineligible.
Beskrivning

Steroids, anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0003280
any patient testing positive for hiv (aids) or hepatitis b or c will be ineligible.
Beskrivning

HIV, Hep B, Hep c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
any female patient known or found to be pregnant will be considered ineligible. patients of childbearing potential unwilling to practice contraception will be ineligible.
Beskrivning

Pregnancy, contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
any patient with an active second malignancy (excluding treated skin cancers or carcinoma in situ) will be ineligible.
Beskrivning

malignancies

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007114
UMLS CUI [3]
C0007099
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Similar models

Eligibility Breast Neoplasm NCT00001507

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
age
Item
age greater or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
breast cancer, inflammatory / invasive, matastases
Item
all patients must have a histologically confirmed diagnosis of inflammatory breast carcinoma stage iii b. patients with no clinical inflammatory signs but with tumor invasion of dermal lymphatic on histology are eligible. patients with metastatic disease and inflammatory breast carcinoma are not eligible. all pathologic material must be reviewed and confirmed by the department of pathology of the treating institution prior to treatment (there will be no central pathology review).
boolean
C0278601 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
prior chemotherapy
Item
patients may be untreated or may have received prior induction chemotherapy outside the nci. if patients received prior induction chemotherapy, they may not have been unresponsive to it. they may have received chemotherapy either before (neo-adjuvant setting) or after local surgery (adjuvant setting).
boolean
C0392920 (UMLS CUI [1])
C0521982 (UMLS CUI [2])
karnofsky performance, ecog
Item
karnofsky performance status of greater than 70% (ecog 0 or 1).
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
ejection fraction
Item
ejection fraction by muga or 2-d echocardiogram within institution normal limits.
boolean
C0232174 (UMLS CUI [1])
creatinine clearance
Item
creatinine clearance of greater than 60 cc/mm.
boolean
C0373595 (UMLS CUI [1])
ast and alt
Item
ast and alt less than 3 times the upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
bilirubin
Item
bilirubin less than 1.5 (except in cases of gilbert's disease).
boolean
C1278039 (UMLS CUI [1])
anc
Item
anc greater than l000/mm(3).
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count greater than 90,000/mm(3).
boolean
C0005821 (UMLS CUI [1])
dlco
Item
dlco greater than 50%.
boolean
C1516251 (UMLS CUI [1])
Compliance behaviour limited by comorbidity
Item
no history of medical or psychiatric disease which would preclude safe treatment in the view of the principal investigator.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
coagulation disorders, repeated infections
Item
no history of abnormal bleeding tendency or predisposition to repeated infections.
boolean
C0005779 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
informed consent
Item
patients must be able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
inflammatory breast cancer but with metastatic disease
Item
patients with inflammatory breast cancer but with metastatic disease.
boolean
C0278601 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
participation representing an unacceptable medical or psychiatric risk
Item
any patient may be excluded from this study at the discretion of the principal investigator if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Steroids, anticoagulants
Item
any patient with a need for chronic steroids or anticoagulation will be ineligible.
boolean
C0038317 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
HIV, Hep B, Hep c
Item
any patient testing positive for hiv (aids) or hepatitis b or c will be ineligible.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy, contraception
Item
any female patient known or found to be pregnant will be considered ineligible. patients of childbearing potential unwilling to practice contraception will be ineligible.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
malignancies
Item
any patient with an active second malignancy (excluding treated skin cancers or carcinoma in situ) will be ineligible.
boolean
C0006826 (UMLS CUI [1])
C0007114 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
Tillbaka till toppen 

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