ID

37810

Descripción

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00909441

Link

https://clinicaltrials.gov/show/NCT00909441

Palabras clave

Versiones (1)
  1. 25/8/19 25/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

25 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00909441

Inglés

Eligibility Breast Cancer NCT00909441

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be female.
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
patients must be 18 years of age or older.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with stage iia, iib, iiia (t1-3 and n1-2) breast cancer. clinical n0 accepted if biopsy proven node disease.
Descripción

Breast Carcinoma TNM Breast tumor staging | Disorder of lymph node TNM Breast tumor staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0272394
UMLS CUI [2,2]
C0474926
patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
Descripción

Disorder of axilla Positive Core needle biopsy | Disorder of axilla Positive Fine needle aspiration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1290870
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1318309
UMLS CUI [2,1]
C1290870
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C1510483
patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
Descripción

Neoadjuvant Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
patients with bilateral breast cancer are eligible. sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
Descripción

Bilateral breast cancer | Breast Contralateral Sentinel Lymph Node Biopsy | Disorder of axilla Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C0441988
UMLS CUI [2,3]
C0796693
UMLS CUI [3,1]
C1290870
UMLS CUI [3,2]
C0332197
patients that understand, accept and have signed the approved consent form.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with inflammatory breast cancer.
Descripción

Inflammatory Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278601
patient with stage iiib, iiic or iv breast cancer (t4 and n3) patients with clinical n3 disease are excluded.
Descripción

Breast Carcinoma TNM Breast tumor staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
Descripción

Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy Axillary | Excision biopsy allowed | Tumorectomy Ipsilateral allowed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0193867
UMLS CUI [2,1]
C0796693
UMLS CUI [2,2]
C0004454
UMLS CUI [3,1]
C0184921
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C3267186
UMLS CUI [4,2]
C0441989
UMLS CUI [4,3]
C0683607
patients that have had previous radiotherapy to the axillary nodes
Descripción

Radiotherapy to lymph nodes Axillary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1504399
UMLS CUI [1,2]
C0004454
patients that have had mammary reduction
Descripción

Reduction mammaplasty

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0191922
patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
Descripción

Patients Medically unfit Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0392920
if the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue or methylene blue or radiocolloid dye are ineligible.
Descripción

Injection Blue dye Planned | Ineligibility Hypersensitivity Iso-sulfan blue | Ineligibility Hypersensitivity Acid blue 3 | Ineligibility Hypersensitivity Methylene blue | Ineligibility Hypersensitivity Colloids Radioactive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C1509231
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0063908
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0020517
UMLS CUI [3,3]
C0070139
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0020517
UMLS CUI [4,3]
C0025746
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C0020517
UMLS CUI [5,3]
C0009361
UMLS CUI [5,4]
C0034553
patients who are pregnant or breast feeding .
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.
Descripción

Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
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Similar models

Eligibility Breast Cancer NCT00909441

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Gender
Item
patients must be female.
boolean
C0079399 (UMLS CUI [1])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging | Disorder of lymph node TNM Breast tumor staging
Item
patients with stage iia, iib, iiia (t1-3 and n1-2) breast cancer. clinical n0 accepted if biopsy proven node disease.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0272394 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
Disorder of axilla Positive Core needle biopsy | Disorder of axilla Positive Fine needle aspiration
Item
patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
boolean
C1290870 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C1290870 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1510483 (UMLS CUI [2,3])
Neoadjuvant Chemotherapy
Item
patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Bilateral breast cancer | Breast Contralateral Sentinel Lymph Node Biopsy | Disorder of axilla Absent
Item
patients with bilateral breast cancer are eligible. sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
boolean
C0281267 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0796693 (UMLS CUI [2,3])
C1290870 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
patients that understand, accept and have signed the approved consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory Breast Carcinoma
Item
patients with inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
patient with stage iiib, iiic or iv breast cancer (t4 and n3) patients with clinical n3 disease are excluded.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy Axillary | Excision biopsy allowed | Tumorectomy Ipsilateral allowed
Item
patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
boolean
C0193867 (UMLS CUI [1])
C0796693 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0184921 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C3267186 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Radiotherapy to lymph nodes Axillary
Item
patients that have had previous radiotherapy to the axillary nodes
boolean
C1504399 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
Reduction mammaplasty
Item
patients that have had mammary reduction
boolean
C0191922 (UMLS CUI [1])
Patients Medically unfit Chemotherapy
Item
patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Injection Blue dye Planned | Ineligibility Hypersensitivity Iso-sulfan blue | Ineligibility Hypersensitivity Acid blue 3 | Ineligibility Hypersensitivity Methylene blue | Ineligibility Hypersensitivity Colloids Radioactive
Item
if the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue or methylene blue or radiocolloid dye are ineligible.
boolean
C1533685 (UMLS CUI [1,1])
C1509231 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1512714 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0063908 (UMLS CUI [2,3])
C1512714 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0070139 (UMLS CUI [3,3])
C1512714 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C0025746 (UMLS CUI [4,3])
C1512714 (UMLS CUI [5,1])
C0020517 (UMLS CUI [5,2])
C0009361 (UMLS CUI [5,3])
C0034553 (UMLS CUI [5,4])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breast feeding .
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance
Item
psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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