ID

21152

Descrizione

Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00507611

collegamento

https://clinicaltrials.gov/show/NCT00507611

Keywords

  1. 12/04/17 12/04/17 -
Caricato su

12 aprile 2017

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Invasive Breast Cancer NCT00507611

Eligibility Invasive Breast Cancer NCT00507611

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 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
patients must have a clinical t1, t2, or t3 tumor size.
Descrizione

TNM clinical staging | Tumor size

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0475440
patients must have a histopathologic tissue diagnosis of breast cancer by a core-type of breast biopsy
Descrizione

Breast Carcinoma Core biopsy of breast

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0842740
patients must have had biopsy-proven involvement of the axillary lymph nodes at initial presentation based on fine needle aspiration (fna) cytology, core/tru-cut biopsy, or pre-treatment sln biopsy that will require an axillary lymph node dissection to be performed at the time of the definitive breast cancer surgery.
Descrizione

Axillary Lymph Node Involvement Biopsy | fine needle aspiration for cytology | Core needle biopsy | Tru-cut biopsy of breast | Sentinel Lymph Node Biopsy pre treatment | Excision of axillary lymph nodes Patient need for | Breast Carcinoma Operative Surgical Procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0741343
UMLS CUI [1,2]
C0005558
UMLS CUI [2]
C2236896
UMLS CUI [3]
C1318309
UMLS CUI [4]
C0554407
UMLS CUI [5,1]
C0796693
UMLS CUI [5,2]
C2709094
UMLS CUI [6,1]
C0193867
UMLS CUI [6,2]
C0686904
UMLS CUI [7,1]
C0678222
UMLS CUI [7,2]
C0543467
patients will have had to undergone preoperative neoadjuvant systemic chemotherapy.
Descrizione

Systemic Chemotherapy Neoadjuvant Preoperative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0445204
patients may be candidates for either lumpectomy or mastectomy.
Descrizione

Indication Lumpectomy | Indication Mastectomy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0024885
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0024881
patients may have a history of a previously treated metachronous contralateral breast cancer in the past.
Descrizione

Contralateral breast cancer Metachronous Treated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1096616
UMLS CUI [1,2]
C1334703
UMLS CUI [1,3]
C1522326
patients may have synchronous bilateral breast cancer.
Descrizione

Bilateral breast cancer Synchronous

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439580
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not be pregnant (the absence of pregnancy must be documented by any one of the following: negative serum pregnancy test, the history of surgical sterilization, or the absence of menstruation for at least six months prior to enrollment in the study)
Descrizione

Pregnancy | Serum pregnancy test negative | Female Sterilization | Menstruation absent Duration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430061
UMLS CUI [3]
C0015787
UMLS CUI [4,1]
C0497456
UMLS CUI [4,2]
C0449238
patients may not have a history of previous treated ipsilateral breast cancer in the past.
Descrizione

Breast Carcinoma Ipsilateral Treated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C1522326

Similar models

Eligibility Invasive Breast Cancer NCT00507611

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
patients must be female and 18 years of age or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
TNM clinical staging | Tumor size
Item
patients must have a clinical t1, t2, or t3 tumor size.
boolean
C3258246 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
Breast Carcinoma Core biopsy of breast
Item
patients must have a histopathologic tissue diagnosis of breast cancer by a core-type of breast biopsy
boolean
C0678222 (UMLS CUI [1,1])
C0842740 (UMLS CUI [1,2])
Axillary Lymph Node Involvement Biopsy | fine needle aspiration for cytology | Core needle biopsy | Tru-cut biopsy of breast | Sentinel Lymph Node Biopsy pre treatment | Excision of axillary lymph nodes Patient need for | Breast Carcinoma Operative Surgical Procedure
Item
patients must have had biopsy-proven involvement of the axillary lymph nodes at initial presentation based on fine needle aspiration (fna) cytology, core/tru-cut biopsy, or pre-treatment sln biopsy that will require an axillary lymph node dissection to be performed at the time of the definitive breast cancer surgery.
boolean
C0741343 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2236896 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
C0554407 (UMLS CUI [4])
C0796693 (UMLS CUI [5,1])
C2709094 (UMLS CUI [5,2])
C0193867 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C0678222 (UMLS CUI [7,1])
C0543467 (UMLS CUI [7,2])
Systemic Chemotherapy Neoadjuvant Preoperative
Item
patients will have had to undergone preoperative neoadjuvant systemic chemotherapy.
boolean
C1883256 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
Indication Lumpectomy | Indication Mastectomy
Item
patients may be candidates for either lumpectomy or mastectomy.
boolean
C3146298 (UMLS CUI [1,1])
C0024885 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0024881 (UMLS CUI [2,2])
Contralateral breast cancer Metachronous Treated
Item
patients may have a history of a previously treated metachronous contralateral breast cancer in the past.
boolean
C1096616 (UMLS CUI [1,1])
C1334703 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Bilateral breast cancer Synchronous
Item
patients may have synchronous bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Serum pregnancy test negative | Female Sterilization | Menstruation absent Duration
Item
patients must not be pregnant (the absence of pregnancy must be documented by any one of the following: negative serum pregnancy test, the history of surgical sterilization, or the absence of menstruation for at least six months prior to enrollment in the study)
boolean
C0032961 (UMLS CUI [1])
C0430061 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0497456 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
Breast Carcinoma Ipsilateral Treated
Item
patients may not have a history of previous treated ipsilateral breast cancer in the past.
boolean
C0678222 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])

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