ID

21238

Description

Ultrasound Targeting for the Lumpectomy Cavity; ODM derived from: https://clinicaltrials.gov/show/NCT00583843

Link

https://clinicaltrials.gov/show/NCT00583843

Keywords

Versions (1)
  1. 4/16/17 4/16/17 -
Uploaded on

April 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00583843

English

Eligibility Breast Neoplasms NCT00583843

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand and the willingness to sign a written informed consent document.
Description

written informed consent ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
patients must have histologically or cytologically confirmed breast carcinoma with voluntarily elected breast conservation techniques (i.e., lumpectomy)
Description

breast carcinoma histology or cytology, breast conservation techniques

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C0010819
UMLS CUI [2]
C0917927
age >18 years. breast cancer, while not restricted only to adult women, is rare in the younger population.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
radiation indicated as a post-surgical adjuvant treatment for breast conservation.
Description

adjuvant radiation indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C1706721
UMLS CUI [1,2]
C1444656
life expectancy of greater than 6 months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
karnofsky of greater or equal to 60
Description

ID.6

Data type

boolean

the effects of radiation therapy on the developing human fetus at the recommended therapeutic dose can be abortifacient. for this reason, and because radiation therapy is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

adequate contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Description

drug adverse events

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
the inability to visualize or reliably contour the lumpectomy cavity from the radiation oncology treatment planning ct scan.
Description

visibility of lumpectomy cavity in planning ct

Data type

boolean

Alias
UMLS CUI [1,1]
C0475644
UMLS CUI [1,2]
C0851238
UMLS CUI [1,3]
C0205379
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the principal investigator.
Description

intercurrent illness limiting compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3640977
UMLS CUI [1,2]
C1321605
pregnant women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with standard chemotherapeutic regimens (if applicable), breastfeeding should be discontinued if the mother is treated any adjuvant chemotherapy.
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Neoplasms NCT00583843

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent ability
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
breast carcinoma histology or cytology, breast conservation techniques
Item
patients must have histologically or cytologically confirmed breast carcinoma with voluntarily elected breast conservation techniques (i.e., lumpectomy)
boolean
C0678222 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,3])
C0917927 (UMLS CUI [2])
age
Item
age >18 years. breast cancer, while not restricted only to adult women, is rare in the younger population.
boolean
C0001779 (UMLS CUI [1])
adjuvant radiation indicated
Item
radiation indicated as a post-surgical adjuvant treatment for breast conservation.
boolean
C1706721 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
life expectancy
Item
life expectancy of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
ID.6
Item
karnofsky of greater or equal to 60
boolean
adequate contraception
Item
the effects of radiation therapy on the developing human fetus at the recommended therapeutic dose can be abortifacient. for this reason, and because radiation therapy is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
drug adverse events
Item
patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
visibility of lumpectomy cavity in planning ct
Item
the inability to visualize or reliably contour the lumpectomy cavity from the radiation oncology treatment planning ct scan.
boolean
C0475644 (UMLS CUI [1,1])
C0851238 (UMLS CUI [1,2])
C0205379 (UMLS CUI [1,3])
brain metastases
Item
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
boolean
C0220650 (UMLS CUI [1])
intercurrent illness limiting compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the principal investigator.
boolean
C3640977 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
pregnancy, breast feeding
Item
pregnant women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with standard chemotherapeutic regimens (if applicable), breastfeeding should be discontinued if the mother is treated any adjuvant chemotherapy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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