Informações:
Falhas:
ID
35009
Descrição
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma; ODM derived from: https://clinicaltrials.gov/show/NCT02316795
Link
https://clinicaltrials.gov/show/NCT02316795
Palavras-chave
Versões (1)
- 08/02/2019 08/02/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
8 de fevereiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02316795
Eligibility Breast Cancer NCT02316795
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT02316795
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Node-negative breast cancer Staging Sentinel Lymph Node Biopsy | Melanoma Staging Sentinel Lymph Node Biopsy
Item
newly diagnosed with clinically node-negative breast cancer or melanoma being staged with sln biopsy.
boolean
C3160889 (UMLS CUI [1,1])
C0332305 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0025202 (UMLS CUI [2,1])
C0332305 (UMLS CUI [2,2])
C0796693 (UMLS CUI [2,3])
C0332305 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0025202 (UMLS CUI [2,1])
C0332305 (UMLS CUI [2,2])
C0796693 (UMLS CUI [2,3])
Lymphatic Basin Negative Clinical examination
Item
negative nodal basin clinical exam.
boolean
C2986565 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C1513916 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to understand and willing to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Contraindication to surgery
Item
contraindications for surgery.
boolean
C0852649 (UMLS CUI [1])
Investigational New Drugs
Item
receiving any investigational agents.
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Indocyanine Green | Allergic Reaction Investigational New Drugs | Hypersensitivity Iodide | Allergy to seafood
Item
history of allergic reactions attributed to icg or other agents used in the study, including known iodide or seafood allergy.
boolean
C1527304 (UMLS CUI [1,1])
C0021234 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0021966 (UMLS CUI [3,2])
C0685900 (UMLS CUI [4])
C0021234 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0021966 (UMLS CUI [3,2])
C0685900 (UMLS CUI [4])
Comorbidity Uncontrolled | Breast infection | Infection of axilla | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0392317 (UMLS CUI [2])
C1285322 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0205318 (UMLS CUI [1,2])
C0392317 (UMLS CUI [2])
C1285322 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Pregnancy
Item
pregnant.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding. patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with icg dye.
boolean
C0006147 (UMLS CUI [1])