ID

21152

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00507611

Trefwoorden

Versies (1)
  1. 12-04-17 12-04-17 -
Geüploaded op

12 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Invasive Breast Cancer NCT00507611

Engels

Eligibility Invasive Breast Cancer NCT00507611

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be female and 18 years of age or older.
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patients must have a clinical t1, t2, or t3 tumor size.
Beschrijving

TNM clinical staging | Tumor size

Datatype

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
Beschrijving

Breast Carcinoma Core biopsy of breast

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Systemic Chemotherapy Neoadjuvant Preoperative

Datatype

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.
Beschrijving

Indication Lumpectomy | Indication Mastectomy

Datatype

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.
Beschrijving

Contralateral breast cancer Metachronous Treated

Datatype

boolean

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

Bilateral breast cancer Synchronous

Datatype

boolean

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

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)
Beschrijving

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

Datatype

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.
Beschrijving

Breast Carcinoma Ipsilateral Treated

Datatype

boolean

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

Eligibility Invasive Breast Cancer NCT00507611

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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