ID

43629

Description

Study of Tumor and Blood Samples From Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00897728

Link

https://clinicaltrials.gov/show/NCT00897728

Keywords

Versions (2)
  1. 10/25/17 10/25/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00897728

English

Eligibility Breast Cancer NCT00897728

1 forms  
Criteria
Description

Criteria

diagnosis of infiltrating unilateral breast cancer
Description

Invasive carcinoma of breast Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
no in situ disease (ductal or lobular)
Description

Exclusion Criteria | Noninfiltrating Intraductal Carcinoma | Non-infiltrating lobular carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0334381
no invasive bilateral synchronous disease
Description

Exclusion | Invasive Carcinoma Synchronous Bilateral

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1334274
UMLS CUI [2,2]
C0439580
UMLS CUI [2,3]
C0238767
breast cancer at high risk, defined by at least 2 of the following factors:
Description

Breast Carcinoma High risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332167
hormone receptor negative (hr-)
Description

Hormone Receptor Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
axillary node positive
Description

Positive Axillary Lymph Node

Data type

boolean

Alias
UMLS CUI [1]
C0677929
histopathologic grade iii
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
high mitotic index (as defined by the curie institute as > 20 mitoses per 10 high-power fields [hpf])
Description

Index Mitotic High

Data type

boolean

Alias
UMLS CUI [1,1]
C0918012
UMLS CUI [1,2]
C1513354
UMLS CUI [1,3]
C0205250
tumor size ≥ 2 cm
Description

Tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0475440
her2-positive (3 + ihc or fish/ichs positive)
Description

HER2/Neu Positive Immunohistochemistry Positive | HER2/Neu Positive FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C2348909
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C1514241
triple-negative tumors (hr- and her2-negative)
Description

Triple-Negative Breast Cancer

Data type

boolean

Alias
UMLS CUI [1]
C2348819
initial thoracic-abdomino-pelvic and bone scans must be negative
Description

Thorax scan Initial Negative | Abdomen scan Initial Negative | CT of Pelvis Initial Negative | Bone scan Initial Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3888834
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0860675
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0412628
UMLS CUI [3,2]
C0205265
UMLS CUI [3,3]
C1513916
UMLS CUI [4,1]
C0203668
UMLS CUI [4,2]
C0205265
UMLS CUI [4,3]
C1513916
underwent initial surgery
Description

Operative Surgical Procedures Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205265
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
serum calcium normal (15.3 mg/dl) or normalized within 8 weeks after surgery
Description

Serum calcium normal | Serum Calcium Normalized Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0858094
UMLS CUI [2,1]
C0036785
UMLS CUI [2,2]
C1882115
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0543467
no other invasive cancer within the past 5 years
Description

Exclusion | Invasive cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0677898
UMLS CUI [2,2]
C0205394
not pregnant or nursing
Description

Exclusion Criteria | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
no psychological, familial, social, or geographical reasons that make monitoring impossible
Description

Exclusion | Factor Monitoring Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1283169
UMLS CUI [2,3]
C1272705
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.21

Data type

boolean

Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00897728

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast Unilateral
Item
diagnosis of infiltrating unilateral breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Exclusion Criteria | Noninfiltrating Intraductal Carcinoma | Non-infiltrating lobular carcinoma
Item
no in situ disease (ductal or lobular)
boolean
C0680251 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0334381 (UMLS CUI [3])
Exclusion | Invasive Carcinoma Synchronous Bilateral
Item
no invasive bilateral synchronous disease
boolean
C2828389 (UMLS CUI [1])
C1334274 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
Breast Carcinoma High risk
Item
breast cancer at high risk, defined by at least 2 of the following factors:
boolean
C0678222 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Hormone Receptor Negative
Item
hormone receptor negative (hr-)
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Positive Axillary Lymph Node
Item
axillary node positive
boolean
C0677929 (UMLS CUI [1])
TNM Breast tumor staging
Item
histopathologic grade iii
boolean
C0474926 (UMLS CUI [1])
Index Mitotic High
Item
high mitotic index (as defined by the curie institute as > 20 mitoses per 10 high-power fields [hpf])
boolean
C0918012 (UMLS CUI [1,1])
C1513354 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Tumor size
Item
tumor size ≥ 2 cm
boolean
C0475440 (UMLS CUI [1])
HER2/Neu Positive Immunohistochemistry Positive | HER2/Neu Positive FISH Positive
Item
her2-positive (3 + ihc or fish/ichs positive)
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Triple-Negative Breast Cancer
Item
triple-negative tumors (hr- and her2-negative)
boolean
C2348819 (UMLS CUI [1])
Thorax scan Initial Negative | Abdomen scan Initial Negative | CT of Pelvis Initial Negative | Bone scan Initial Negative
Item
initial thoracic-abdomino-pelvic and bone scans must be negative
boolean
C3888834 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0860675 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0412628 (UMLS CUI [3,1])
C0205265 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
C0203668 (UMLS CUI [4,1])
C0205265 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
Operative Surgical Procedures Initial
Item
underwent initial surgery
boolean
C0543467 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Serum calcium normal | Serum Calcium Normalized Post Operative Surgical Procedures
Item
serum calcium normal (15.3 mg/dl) or normalized within 8 weeks after surgery
boolean
C0858094 (UMLS CUI [1])
C0036785 (UMLS CUI [2,1])
C1882115 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
Exclusion | Invasive cancer Other
Item
no other invasive cancer within the past 5 years
boolean
C2828389 (UMLS CUI [1])
C0677898 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Exclusion | Factor Monitoring Unsuccessful
Item
no psychological, familial, social, or geographical reasons that make monitoring impossible
boolean
C2828389 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C1283169 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial