Informações:
Falhas:
ID
21238
Descrição
Ultrasound Targeting for the Lumpectomy Cavity; ODM derived from: https://clinicaltrials.gov/show/NCT00583843
Link
https://clinicaltrials.gov/show/NCT00583843
Palavras-chave
Versões (1)
- 16/04/2017 16/04/2017 -
Transferido a
16 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00583843
Eligibility Breast Neoplasms NCT00583843
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT00583843
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
C0006147 (UMLS CUI [2])