ID

19648

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.01.17 18.01.17 -
Hochgeladen am

18. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00897208

Englisch

Eligibility Breast Cancer NCT00897208

1 Formulare  
Criteria
Beschreibung

Criteria

meets 1 of the following criteria:
Beschreibung

criteria Fulfill

Datentyp

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
Beschreibung

Breast Carcinoma TNM clinical staging

Datentyp

boolean

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

Disease Negative Lymph Node | Disease lymph node positive

Datentyp

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
Beschreibung

Noninfiltrating Intraductal Carcinoma TNM clinical staging

Datentyp

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:
Beschreibung

At high risk for breast cancer

Datentyp

boolean

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

Risk Percentage Year Quantity Gail Risk Model

Datentyp

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%
Beschreibung

Lifetime Risk Percentage Gail Risk Model

Datentyp

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
Beschreibung

BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

Breast Carcinoma Low Risk | Breast Carcinoma Risk Average

Datentyp

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%
Beschreibung

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

Datentyp

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
Beschreibung

Advanced breast cancer

Datentyp

boolean

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

Hormone Receptor Status Unspecified

Datentyp

boolean

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

Client Characteristics

Datentyp

boolean

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

Premenopausal state | Postmenopausal state

Datentyp

boolean

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

Therapeutic procedure

Datentyp

boolean

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

Chemotherapy Breast Carcinoma | Chemotherapy Malignant Neoplasms

Datentyp

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
Beschreibung

Estrogen hormone therapy | Hormone Therapy

Datentyp

boolean

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

Contraceptives, Oral

Datentyp

boolean

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

Selective Estrogen Receptor Modulators | Tamoxifen Citrate | Raloxifene

Datentyp

boolean

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

Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0593802
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Ähnliche Modelle

Eligibility Breast Cancer NCT00897208

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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