ID

38361

Description

Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02279108

Link

https://clinicaltrials.gov/show/NCT02279108

Keywords

Versions (1)
  1. 10/12/19 10/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02279108

English

Eligibility Breast Neoplasms NCT02279108

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (high grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
Description

Invasive carcinoma of breast | Invasive Ductal Breast Carcinoma | Breast cancer, lobular | Carcinoma in Situ High risk Microinvasive | Invasive carcinoma of breast Severe with Necrosis | Tumor size Radiology | Mastectomy Immediate

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C1134719
UMLS CUI [3]
C3549742
UMLS CUI [4,1]
C0007099
UMLS CUI [4,2]
C4319571
UMLS CUI [4,3]
C3853531
UMLS CUI [5,1]
C0853879
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0332287
UMLS CUI [5,4]
C0027540
UMLS CUI [6,1]
C0475440
UMLS CUI [6,2]
C0043299
UMLS CUI [7,1]
C0024881
UMLS CUI [7,2]
C0205253
unifocal or multifocal but in same quarter
Description

Invasive carcinoma of breast Unifocal | Invasive carcinoma of breast Multifocal Breast quadrant Same

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0443337
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205292
UMLS CUI [2,3]
C0447660
UMLS CUI [2,4]
C0445247
size < 5cm clinically palpable or not
Description

Tumor size Palpable | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0522499
UMLS CUI [2]
C0475440
clinically or ultrasound axillary n0
Description

Axillary lymph nodes TNM clinical staging Clinical examination | Axillary lymph nodes TNM clinical staging Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C0041618
isotopic sentinel node detection
Description

Detection Sentinel Lymph Node Isotopic

Data type

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C1522495
UMLS CUI [1,3]
C4038403
adult patient
Description

Adult

Data type

boolean

Alias
UMLS CUI [1]
C0001675
signed informed consent by patient or legally responsable authority
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient registered to a social security system
Description

Patient registered Social Security Program

Data type

boolean

Alias
UMLS CUI [1,1]
C0585825
UMLS CUI [1,2]
C0037435
no surgical contra-indication
Description

Medical contraindication Absent Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0543467
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mammary carcinoma recurrence
Description

Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0278493
previous same side mammary reduction
Description

Reduction mammaplasty Ipsilateral Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0191922
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0205156
previous lumpectomy
Description

Segmental Mastectomy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0024885
UMLS CUI [1,2]
C0205156
contra-indication to surgery
Description

Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
pregnant or breast feeding patient
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
denial of participation
Description

Study Subject Participation Status | Refusal to Participate

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1136454
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Similar models

Eligibility Breast Neoplasms NCT02279108

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Invasive Ductal Breast Carcinoma | Breast cancer, lobular | Carcinoma in Situ High risk Microinvasive | Invasive carcinoma of breast Severe with Necrosis | Tumor size Radiology | Mastectomy Immediate
Item
histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (high grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
boolean
C0853879 (UMLS CUI [1])
C1134719 (UMLS CUI [2])
C3549742 (UMLS CUI [3])
C0007099 (UMLS CUI [4,1])
C4319571 (UMLS CUI [4,2])
C3853531 (UMLS CUI [4,3])
C0853879 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0332287 (UMLS CUI [5,3])
C0027540 (UMLS CUI [5,4])
C0475440 (UMLS CUI [6,1])
C0043299 (UMLS CUI [6,2])
C0024881 (UMLS CUI [7,1])
C0205253 (UMLS CUI [7,2])
Invasive carcinoma of breast Unifocal | Invasive carcinoma of breast Multifocal Breast quadrant Same
Item
unifocal or multifocal but in same quarter
boolean
C0853879 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C0447660 (UMLS CUI [2,3])
C0445247 (UMLS CUI [2,4])
Tumor size Palpable | Tumor size
Item
size < 5cm clinically palpable or not
boolean
C0475440 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
Axillary lymph nodes TNM clinical staging Clinical examination | Axillary lymph nodes TNM clinical staging Ultrasonography
Item
clinically or ultrasound axillary n0
boolean
C0729594 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0729594 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
Detection Sentinel Lymph Node Isotopic
Item
isotopic sentinel node detection
boolean
C1511790 (UMLS CUI [1,1])
C1522495 (UMLS CUI [1,2])
C4038403 (UMLS CUI [1,3])
Adult
Item
adult patient
boolean
C0001675 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
signed informed consent by patient or legally responsable authority
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Patient registered Social Security Program
Item
patient registered to a social security system
boolean
C0585825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
Medical contraindication Absent Operative Surgical Procedures
Item
no surgical contra-indication
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent
Item
mammary carcinoma recurrence
boolean
C0278493 (UMLS CUI [1])
Reduction mammaplasty Ipsilateral Previous
Item
previous same side mammary reduction
boolean
C0191922 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Segmental Mastectomy Previous
Item
previous lumpectomy
boolean
C0024885 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical contraindication Operative Surgical Procedures
Item
contra-indication to surgery
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding patient
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Refusal to Participate
Item
denial of participation
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2])
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