ID

38102

Description

Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01669265

Link

https://clinicaltrials.gov/show/NCT01669265

Keywords

Versions (1)
  1. 9/17/19 9/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01669265

English

Eligibility Breast Cancer NCT01669265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed invasive breast carcinoma
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
stage t1-3,n0 evaluated by physical exam or imaging according to ajcc v.7 and best clinical local practices
Description

TNM Breast tumor staging Physical Examination | TNM Breast tumor staging Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0474926
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0474926
UMLS CUI [2,2]
C0011923
intraoperative evaluation of sentinel lymph node (sln) by osna
Description

Sentinel Lymph Node Evaluation Intraoperative | Sentinel Lymph Node Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0456904
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C0936012
complete dissection of axillary lymph nodes after the evaluation of the slns by osna
Description

Excision of axillary lymph nodes Complete | Status post Sentinel Lymph Node Evaluation | Status post Sentinel Lymph Node Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522495
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522495
UMLS CUI [3,3]
C0936012
pathology report of the tumor and dissected lymph nodes that includes the following information:
Description

Pathology report Neoplasm | Pathology report Lymph node excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0807321
UMLS CUI [1,2]
C0027651
UMLS CUI [2,1]
C0807321
UMLS CUI [2,2]
C0024203
primary tumor size (mm), tumor grade (scarff-bloom richardson), estrogen receptor status
Description

Tumor size | Neoplasm Grade Scarff-Bloom-Richardson Grading System | Estrogen Receptor Status

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C3828224
UMLS CUI [3,1]
C0034804
UMLS CUI [3,2]
C0449438
progesterone receptor status
Description

Progesterone Receptor Status

Data type

boolean

Alias
UMLS CUI [1]
C1514471
her2 status (asco/cap guidelines)
Description

HER2 Status

Data type

boolean

Alias
UMLS CUI [1]
C1512413
ki67 index
Description

Ki67 Measurement

Data type

boolean

Alias
UMLS CUI [1]
C4049944
presence/absence of lymphovascular invasion
Description

Lymphatic Invasion Present | Lymphatic Invasion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1708790
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C1708790
UMLS CUI [2,2]
C0332197
total number of sentinel and non-sentinel lymph nodes dissected during surgery
Description

Sentinel Lymph Node Total Number Excision | Lymph nodes Total Number Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C4288115
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C4288115
UMLS CUI [2,3]
C0728940
total number of positive and negative sentinel and non-sentinel lymph nodes,
Description

Sentinel Lymph Node Positive Total Number | Lymph node positive Total Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C4288115
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C4288115
*size of the metastasis in both sentinel and non-sentinel lymph nodes
Description

Sentinel Lymph Node Neoplasm Metastasis Size | Secondary malignant neoplasm of lymph node Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0456389
total tumoral load in each sentinel lymph node, expressed as number of ck19 mrna copies per microliter.
Description

Tumor Burden Sentinel Lymph Node | CK19 Expression

Data type

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C1522495
UMLS CUI [2,1]
C1334314
UMLS CUI [2,2]
C0017262
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who underwent neoadjuvant chemotherapy
Description

Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
ck19-negative breast tumor
Description

Breast Carcinoma CK19 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C4082253
UMLS CUI [1,3]
C1513916
alnd with <10 lymph nodes
Description

Excision of axillary lymph nodes Lymph nodes Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1265611
in situ carcinoma only
Description

Carcinoma in Situ only

Data type

boolean

Alias
UMLS CUI [1,1]
C0007099
UMLS CUI [1,2]
C0205171
metastatic breast cancer at time of diagnosis
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
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Similar models

Eligibility Breast Cancer NCT01669265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
pathologically confirmed invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
TNM Breast tumor staging Physical Examination | TNM Breast tumor staging Imaging
Item
stage t1-3,n0 evaluated by physical exam or imaging according to ajcc v.7 and best clinical local practices
boolean
C0474926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0474926 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Sentinel Lymph Node Evaluation Intraoperative | Sentinel Lymph Node Analysis
Item
intraoperative evaluation of sentinel lymph node (sln) by osna
boolean
C1522495 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0456904 (UMLS CUI [1,3])
C1522495 (UMLS CUI [2,1])
C0936012 (UMLS CUI [2,2])
Excision of axillary lymph nodes Complete | Status post Sentinel Lymph Node Evaluation | Status post Sentinel Lymph Node Analysis
Item
complete dissection of axillary lymph nodes after the evaluation of the slns by osna
boolean
C0193867 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522495 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1522495 (UMLS CUI [3,2])
C0936012 (UMLS CUI [3,3])
Pathology report Neoplasm | Pathology report Lymph node excision
Item
pathology report of the tumor and dissected lymph nodes that includes the following information:
boolean
C0807321 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0807321 (UMLS CUI [2,1])
C0024203 (UMLS CUI [2,2])
Tumor size | Neoplasm Grade Scarff-Bloom-Richardson Grading System | Estrogen Receptor Status
Item
primary tumor size (mm), tumor grade (scarff-bloom richardson), estrogen receptor status
boolean
C0475440 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C3828224 (UMLS CUI [2,3])
C0034804 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
Progesterone Receptor Status
Item
progesterone receptor status
boolean
C1514471 (UMLS CUI [1])
HER2 Status
Item
her2 status (asco/cap guidelines)
boolean
C1512413 (UMLS CUI [1])
Ki67 Measurement
Item
ki67 index
boolean
C4049944 (UMLS CUI [1])
Lymphatic Invasion Present | Lymphatic Invasion Absent
Item
presence/absence of lymphovascular invasion
boolean
C1708790 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1708790 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Sentinel Lymph Node Total Number Excision | Lymph nodes Total Number Excision
Item
total number of sentinel and non-sentinel lymph nodes dissected during surgery
boolean
C1522495 (UMLS CUI [1,1])
C4288115 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0024204 (UMLS CUI [2,1])
C4288115 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Sentinel Lymph Node Positive Total Number | Lymph node positive Total Number
Item
total number of positive and negative sentinel and non-sentinel lymph nodes,
boolean
C1522495 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C4288115 (UMLS CUI [1,3])
C0746319 (UMLS CUI [2,1])
C4288115 (UMLS CUI [2,2])
Sentinel Lymph Node Neoplasm Metastasis Size | Secondary malignant neoplasm of lymph node Size
Item
*size of the metastasis in both sentinel and non-sentinel lymph nodes
boolean
C1522495 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0686619 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Tumor Burden Sentinel Lymph Node | CK19 Expression
Item
total tumoral load in each sentinel lymph node, expressed as number of ck19 mrna copies per microliter.
boolean
C1449699 (UMLS CUI [1,1])
C1522495 (UMLS CUI [1,2])
C1334314 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Neoadjuvant Chemotherapy
Item
patients who underwent neoadjuvant chemotherapy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Breast Carcinoma CK19 Negative
Item
ck19-negative breast tumor
boolean
C0678222 (UMLS CUI [1,1])
C4082253 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Excision of axillary lymph nodes Lymph nodes Quantity
Item
alnd with <10 lymph nodes
boolean
C0193867 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Carcinoma in Situ only
Item
in situ carcinoma only
boolean
C0007099 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer at time of diagnosis
boolean
C0346993 (UMLS CUI [1])
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