ID

19648

Description

Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00897208

Link

https://clinicaltrials.gov/show/NCT00897208

Keywords

Versions (1)
  1. 1/18/17 1/18/17 -
Uploaded on

January 18, 2017

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 NCT00897208

English

Eligibility Breast Cancer NCT00897208

1 forms  
Criteria
Description

Criteria

meets 1 of the following criteria:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
newly diagnosed (within 30 calendar days of diagnosis) stage i or ii breast cancer
Description

Breast Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
node-negative or node-positive disease
Description

Disease Negative Lymph Node | Disease lymph node positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678034
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0746319
newly diagnosed ductal carcinoma in situ (stage 0) of the breast
Description

Noninfiltrating Intraductal Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C3258246
at high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
Description

At high risk for breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C4047809
gail model 5-year risk score ≥ 1.66%
Description

Risk Percentage Year Quantity Gail Risk Model

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0439234
UMLS CUI [1,4]
C1265611
UMLS CUI [1,5]
C1511297
gail model lifetime-risk estimate ≥ 20%
Description

Lifetime Risk Percentage Gail Risk Model

Data type

boolean

Alias
UMLS CUI [1,1]
C1517878
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1511297
known deleterious brca 1 or 2 gene mutation carrier
Description

BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious

Data type

boolean

Alias
UMLS CUI [1,1]
C3899965
UMLS CUI [1,2]
C2985436
UMLS CUI [2,1]
C3899964
UMLS CUI [2,2]
C2985436
history of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
Description

Non-infiltrating lobular carcinoma | Atypical ductal hyperplasia | Atypical lobular hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0334381
UMLS CUI [2]
C0442834
UMLS CUI [3]
C0442835
at low or average risk of developing breast cancer (control group)
Description

Breast Carcinoma Low Risk | Breast Carcinoma Risk Average

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3538919
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1510992
gail model 5-year risk score < 1.66% or lifetime risk < 20%
Description

Risk Percentage Year Quantity Gail Risk Model | Lifetime Risk Percentage Gail Risk Model

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0439234
UMLS CUI [1,4]
C1265611
UMLS CUI [1,5]
C1511297
UMLS CUI [2,1]
C1517878
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1511297
no advanced breast cancer
Description

Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C3495917
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
pre- or post-menopausal
Description

Premenopausal state | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior chemotherapy for breast cancer or any other cancer
Description

Chemotherapy Breast Carcinoma | Chemotherapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0006826
more than 3 months since prior and no concurrent estrogen or other hormones
Description

Estrogen hormone therapy | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0474186
UMLS CUI [2]
C0279025
more than 3 months since prior oral contraceptives
Description

Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009905
no concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
Description

Selective Estrogen Receptor Modulators | Tamoxifen Citrate | Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0732611
UMLS CUI [2]
C0079589
UMLS CUI [3]
C0244404
no concurrent aromatase inhibitors
Description

Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0593802
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00897208

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
criteria Fulfill
Item
meets 1 of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Breast Carcinoma TNM clinical staging
Item
newly diagnosed (within 30 calendar days of diagnosis) stage i or ii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease Negative Lymph Node | Disease lymph node positive
Item
node-negative or node-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0678034 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0746319 (UMLS CUI [2,2])
Noninfiltrating Intraductal Carcinoma TNM clinical staging
Item
newly diagnosed ductal carcinoma in situ (stage 0) of the breast
boolean
C0007124 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
At high risk for breast cancer
Item
at high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
boolean
C4047809 (UMLS CUI [1])
Risk Percentage Year Quantity Gail Risk Model
Item
gail model 5-year risk score ≥ 1.66%
boolean
C0035647 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1511297 (UMLS CUI [1,5])
Lifetime Risk Percentage Gail Risk Model
Item
gail model lifetime-risk estimate ≥ 20%
boolean
C1517878 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1511297 (UMLS CUI [1,3])
BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious
Item
known deleterious brca 1 or 2 gene mutation carrier
boolean
C3899965 (UMLS CUI [1,1])
C2985436 (UMLS CUI [1,2])
C3899964 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
Non-infiltrating lobular carcinoma | Atypical ductal hyperplasia | Atypical lobular hyperplasia
Item
history of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
boolean
C0334381 (UMLS CUI [1])
C0442834 (UMLS CUI [2])
C0442835 (UMLS CUI [3])
Breast Carcinoma Low Risk | Breast Carcinoma Risk Average
Item
at low or average risk of developing breast cancer (control group)
boolean
C0678222 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1510992 (UMLS CUI [2,3])
Risk Percentage Year Quantity Gail Risk Model | Lifetime Risk Percentage Gail Risk Model
Item
gail model 5-year risk score < 1.66% or lifetime risk < 20%
boolean
C0035647 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1511297 (UMLS CUI [1,5])
C1517878 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1511297 (UMLS CUI [2,3])
Advanced breast cancer
Item
no advanced breast cancer
boolean
C3495917 (UMLS CUI [1])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Premenopausal state | Postmenopausal state
Item
pre- or post-menopausal
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Chemotherapy Breast Carcinoma | Chemotherapy Malignant Neoplasms
Item
no prior chemotherapy for breast cancer or any other cancer
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Estrogen hormone therapy | Hormone Therapy
Item
more than 3 months since prior and no concurrent estrogen or other hormones
boolean
C0474186 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Contraceptives, Oral
Item
more than 3 months since prior oral contraceptives
boolean
C0009905 (UMLS CUI [1])
Selective Estrogen Receptor Modulators | Tamoxifen Citrate | Raloxifene
Item
no concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
boolean
C0732611 (UMLS CUI [1])
C0079589 (UMLS CUI [2])
C0244404 (UMLS CUI [3])
Aromatase Inhibitors
Item
no concurrent aromatase inhibitors
boolean
C0593802 (UMLS CUI [1])
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