ID

39255

Description

Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02481128

Link

https://clinicaltrials.gov/show/NCT02481128

Keywords

Versions (1)
  1. 12/13/19 12/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Early-Stage Breast Carcinoma NCT02481128

English

Eligibility Early-Stage Breast Carcinoma NCT02481128

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive mamma carcinoma as verified by core cut biopsy
Description

Invasive carcinoma of breast Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1318309
extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and g3 grading)
Description

Ductal carcinoma in situ Extensive TNM Breast tumor staging | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0205231
UMLS CUI [1,3]
C0474926
UMLS CUI [2]
C0475440
clinical stage tumor t1-t3
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
no signs of axillary lymph node metastasis on clinical examination including ultrasound examination
Description

Signs Absent AXILLARY LYMPH NODE METASTASIS | Clinical examination | Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0741344
UMLS CUI [2]
C1456356
UMLS CUI [3]
C0041618
no signs of distant metastatic disease
Description

Signs Absent Distant metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1269798
male/ female patient in the age not less than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status at least 70% or eastern cooperative oncology group (ecog) score not higher than 1
Description

Karnofsky Performance Status | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
written patient informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
suspect axillary lymph nodes on clinical/ultrasound examination
Description

Axillary lymph nodes Suspect Clinical examination | Axillary lymph nodes Suspect Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0041618
positive fine-needle biopsy of axillary lymph nodes
Description

Axillary lymph nodes Positive Fine-needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0085846
sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy
Description

Sentinel Lymph Node Biopsy Perform | Status post Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0884358
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C3665472
recurrence of a mamma carcinoma
Description

Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0278493
prior extensive surgery of breast or axilla
Description

Operation on breast Extensive | Axilla Surgery Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0004454
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0205231
inflammatory or extramammary breast cancer
Description

Inflammatory Breast Carcinoma | Breast Carcinoma Except mammary

Data type

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0006141
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
contraindication to the radionuclide
Description

Medical contraindication Radionuclide

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0034595
inability to understand the studies purpose
Description

Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
inability to receive surgery
Description

Operative Surgical Procedure Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
no written patient informed consent
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Early-Stage Breast Carcinoma NCT02481128

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Core needle biopsy
Item
invasive mamma carcinoma as verified by core cut biopsy
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
Ductal carcinoma in situ Extensive TNM Breast tumor staging | Tumor size
Item
extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and g3 grading)
boolean
C0007124 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2])
TNM Breast tumor staging
Item
clinical stage tumor t1-t3
boolean
C0474926 (UMLS CUI [1])
Signs Absent AXILLARY LYMPH NODE METASTASIS | Clinical examination | Ultrasonography
Item
no signs of axillary lymph node metastasis on clinical examination including ultrasound examination
boolean
C0311392 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0741344 (UMLS CUI [1,3])
C1456356 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
Signs Absent Distant metastasis
Item
no signs of distant metastatic disease
boolean
C0311392 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1269798 (UMLS CUI [1,3])
Age
Item
male/ female patient in the age not less than 18 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
karnofsky performance status at least 70% or eastern cooperative oncology group (ecog) score not higher than 1
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Informed Consent
Item
written patient informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axillary lymph nodes Suspect Clinical examination | Axillary lymph nodes Suspect Ultrasonography
Item
suspect axillary lymph nodes on clinical/ultrasound examination
boolean
C0729594 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0729594 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
Axillary lymph nodes Positive Fine-needle biopsy
Item
positive fine-needle biopsy of axillary lymph nodes
boolean
C0729594 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0085846 (UMLS CUI [1,3])
Sentinel Lymph Node Biopsy Perform | Status post Neoadjuvant Chemotherapy
Item
sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy
boolean
C0796693 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C3665472 (UMLS CUI [2,3])
Breast cancer recurrent
Item
recurrence of a mamma carcinoma
boolean
C0278493 (UMLS CUI [1])
Operation on breast Extensive | Axilla Surgery Extensive
Item
prior extensive surgery of breast or axilla
boolean
C3714726 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0004454 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
Inflammatory Breast Carcinoma | Breast Carcinoma Except mammary
Item
inflammatory or extramammary breast cancer
boolean
C0278601 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical contraindication Radionuclide
Item
contraindication to the radionuclide
boolean
C1301624 (UMLS CUI [1,1])
C0034595 (UMLS CUI [1,2])
Study Protocol Comprehension Unable
Item
inability to understand the studies purpose
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Operative Surgical Procedure Receive Unable
Item
inability to receive surgery
boolean
C0543467 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Informed Consent Lacking
Item
no written patient informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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