Information:
Fel:
ID
12765
Beskrivning
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00754312
Länk
https://clinicaltrials.gov/show/NCT00754312
Nyckelord
Versioner (1)
- 2015-12-21 2015-12-21 -
Uppladdad den
21 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00754312
Eligibility Breast Cancer NCT00754312
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00754312
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
breast biopsy; mammogram
Item
is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
boolean
C0405352 (UMLS CUI [1])
C0024671 (UMLS CUI [2])
C0024671 (UMLS CUI [2])
Medication dose study
Item
must be able to receive two doses of study medication 7 days apart prior to surgery
boolean
C3174092 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
Invasive breast carcinoma
Item
has histologically confirmed invasive breast cancer with er positive, er and/or pr negative histology or triple negative (for er, pr, her-2) histology
boolean
C0853879 (UMLS CUI [1])
ecog performance status
Item
has an ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
abnormalities laboratory; abnormalities cardiac
Item
has no clinically significant laboratory or cardiac abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0022877 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
pregnancy test; Postmenopause
Item
has a negative serum pregnancy test at screening as is either post menopausal, sterile or willing to use an approved method of contraception.
boolean
C0032976 (UMLS CUI [1])
C0206159 (UMLS CUI [2])
C0206159 (UMLS CUI [2])
oral medication
Item
is able to swallow and retain oral medication
boolean
C0175795 (UMLS CUI [1])
comorbidity; Hemorrhage; obesity
Item
has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. bleeding disorders that would increase risks of additional core biopsy for biomarkers, b. morbid obesity
boolean
C0009488 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
C0028754 (UMLS CUI [3])
C0019080 (UMLS CUI [2])
C0028754 (UMLS CUI [3])
concomitant medication
Item
is currently receiving treatment with a medication on the prohibited medication list
boolean
C2347852 (UMLS CUI [1])
hypersensitivity benzamides
Item
has allergy to benzamides or inactive components of study drug
boolean
C0020517 (UMLS CUI [1,1])
C0005029 (UMLS CUI [1,2])
C0005029 (UMLS CUI [1,2])
Study Subject Participation Status
Item
is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent
boolean
C2348568 (UMLS CUI [1])