ID

26568

Beschrijving

Intraoperative Gamma Camera for Breast Cancer Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00757302

Link

https://clinicaltrials.gov/show/NCT00757302

Trefwoorden

Versies (1)
  1. 19-10-17 19-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00757302

Engels

Eligibility Breast Cancer NCT00757302

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient major at the time of breast surgery.
Beschrijving

Adult | Operation on breast

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C3714726
patient affiliated with a social security.
Beschrijving

Social security recipient

Datatype

boolean

Alias
UMLS CUI [1]
C0682299
consent dated and signed by the investigator and the subject.
Beschrijving

Informed Consent | Informed Consent Investigator

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0035173
subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
Beschrijving

Patient Information Sentinel Lymph Node procedure | Patient Visit Before Operation on breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C1955348
UMLS CUI [1,2]
C1522495
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C3714726
patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
Beschrijving

Invasive carcinoma of breast Unifocal Size | Core biopsy | Cytology

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0443337
UMLS CUI [1,3]
C0456389
UMLS CUI [2]
C1318309
UMLS CUI [3]
C1305671
patient having a ductal carcinoma in situ (dcis), diagnosed preoperatively by core biopsy or cytology.
Beschrijving

DCIS Core biopsy | DCIS Cytology

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C1305671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
refusal of the patient to be included in the study.
Beschrijving

Participation Clinical Trial Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1705116
pregnant patient or during breastfeeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
none of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
Beschrijving

Chemotherapy | Therapeutic radiology procedure Local-Regional | Prevalence Axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1947913
UMLS CUI [3,1]
C0220900
UMLS CUI [3,2]
C0729594
diagnosed safeguarding justice and trust.
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
Beschrijving

Mental disorders Informed Consent Unable | Tumor size | Multifocal tumor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0475440
UMLS CUI [3]
C1302461
prevalent axillary lymph node.
Beschrijving

Prevalence Axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220900
UMLS CUI [1,2]
C0729594
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Similar models

Eligibility Breast Cancer NCT00757302

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Operation on breast
Item
patient major at the time of breast surgery.
boolean
C0001675 (UMLS CUI [1])
C3714726 (UMLS CUI [2])
Social security recipient
Item
patient affiliated with a social security.
boolean
C0682299 (UMLS CUI [1])
Informed Consent | Informed Consent Investigator
Item
consent dated and signed by the investigator and the subject.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
Patient Information Sentinel Lymph Node procedure | Patient Visit Before Operation on breast
Item
subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
boolean
C1955348 (UMLS CUI [1,1])
C1522495 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C1512346 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3714726 (UMLS CUI [2,3])
Invasive carcinoma of breast Unifocal Size | Core biopsy | Cytology
Item
patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
boolean
C0853879 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1318309 (UMLS CUI [2])
C1305671 (UMLS CUI [3])
DCIS Core biopsy | DCIS Cytology
Item
patient having a ductal carcinoma in situ (dcis), diagnosed preoperatively by core biopsy or cytology.
boolean
C0007124 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2,1])
C1305671 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Participation Clinical Trial Refused
Item
refusal of the patient to be included in the study.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant patient or during breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure Local-Regional | Prevalence Axillary lymph nodes
Item
none of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0220900 (UMLS CUI [3,1])
C0729594 (UMLS CUI [3,2])
ID.10
Item
diagnosed safeguarding justice and trust.
boolean
C3846158 (UMLS CUI [1])
Mental disorders Informed Consent Unable | Tumor size | Multifocal tumor
Item
patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2])
C1302461 (UMLS CUI [3])
Prevalence Axillary lymph nodes
Item
prevalent axillary lymph node.
boolean
C0220900 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
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