ID

34998

Descrizione

Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02287675

collegamento

https://clinicaltrials.gov/show/NCT02287675

Keywords

versioni (1)
  1. 07/02/19 07/02/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

7 febbraio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02287675

Inglese

Eligibility Breast Cancer NCT02287675

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject must be female and 18 years of age or older.
Descrizione

Gender | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
the subject must be a preoperative clinical tis, t1, t2, t3, t4, as well as clinical n0 and clinical m0 breast cancer
Descrizione

Breast Carcinoma Preoperative TNM Breast tumor staging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0474926
the subject must have a diagnosis of primary breast cancer.
Descrizione

Breast Carcinoma Primary

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
the subject must be a candidate for surgical intervention, either with lumpectomy and slnb or with mastectomy and slnb, as the treatment of her breast cancer.
Descrizione

Patient Appropriate Surgical intervention | Segmental Mastectomy | Sentinel Lymph Node Biopsy | Mastectomy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0549433
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0796693
UMLS CUI [4]
C0024881
the subject must have an eastern cooperative oncology group (ecog) performance status of grade 0 - 2
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
the subject must provide written informed consent with health insurance portability and accountability act (hipaa) authorization before participating in the study
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.
Descrizione

Neoplasm Metastasis | Abnormality of the lymph nodes | Lymphadenopathy Palpable | Malignant cells Lymph nodes Core needle biopsy | Malignant cells Lymph nodes Surgical biopsy | Malignant cells Lymph nodes Fine needle aspiration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0149727
UMLS CUI [3,1]
C0497156
UMLS CUI [3,2]
C0522499
UMLS CUI [4,1]
C0334227
UMLS CUI [4,2]
C0024204
UMLS CUI [4,3]
C1318309
UMLS CUI [5,1]
C0334227
UMLS CUI [5,2]
C0024204
UMLS CUI [5,3]
C0565118
UMLS CUI [6,1]
C0334227
UMLS CUI [6,2]
C0024204
UMLS CUI [6,3]
C1510483
the subject has a known hypersensitivity to vital blue dye (vbd) in a case where vital blue dye was planned for use during slnb.
Descrizione

Other Coding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3846158
the subject has a positive pregnancy test or is lactating.
Descrizione

Pregnancy test positive | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
the subject has had prior surgery to the indicated breast or axilla.
Descrizione

Operative Surgical Procedure Previous Breast Indicated | Operative Surgical Procedure Previous Axilla Indicated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C1444656
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0004454
UMLS CUI [2,4]
C1444656
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Similar models

Eligibility Breast Cancer NCT02287675

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
the subject must be female and 18 years of age or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma Preoperative TNM Breast tumor staging
Item
the subject must be a preoperative clinical tis, t1, t2, t3, t4, as well as clinical n0 and clinical m0 breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Breast Carcinoma Primary
Item
the subject must have a diagnosis of primary breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Patient Appropriate Surgical intervention | Segmental Mastectomy | Sentinel Lymph Node Biopsy | Mastectomy
Item
the subject must be a candidate for surgical intervention, either with lumpectomy and slnb or with mastectomy and slnb, as the treatment of her breast cancer.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
C0024885 (UMLS CUI [2])
C0796693 (UMLS CUI [3])
C0024881 (UMLS CUI [4])
ECOG performance status
Item
the subject must have an eastern cooperative oncology group (ecog) performance status of grade 0 - 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
the subject must provide written informed consent with health insurance portability and accountability act (hipaa) authorization before participating in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Abnormality of the lymph nodes | Lymphadenopathy Palpable | Malignant cells Lymph nodes Core needle biopsy | Malignant cells Lymph nodes Surgical biopsy | Malignant cells Lymph nodes Fine needle aspiration
Item
the subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.
boolean
C0027627 (UMLS CUI [1])
C0149727 (UMLS CUI [2])
C0497156 (UMLS CUI [3,1])
C0522499 (UMLS CUI [3,2])
C0334227 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C1318309 (UMLS CUI [4,3])
C0334227 (UMLS CUI [5,1])
C0024204 (UMLS CUI [5,2])
C0565118 (UMLS CUI [5,3])
C0334227 (UMLS CUI [6,1])
C0024204 (UMLS CUI [6,2])
C1510483 (UMLS CUI [6,3])
Other Coding
Item
the subject has a known hypersensitivity to vital blue dye (vbd) in a case where vital blue dye was planned for use during slnb.
boolean
C3846158 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding
Item
the subject has a positive pregnancy test or is lactating.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Operative Surgical Procedure Previous Breast Indicated | Operative Surgical Procedure Previous Axilla Indicated
Item
the subject has had prior surgery to the indicated breast or axilla.
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1444656 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
C1444656 (UMLS CUI [2,4])
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