ID

27247

Descripción

Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors; ODM derived from: https://clinicaltrials.gov/show/NCT01425476

Link

https://clinicaltrials.gov/show/NCT01425476

Palabras clave

Versiones (1)
  1. 5/11/17 5/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01425476

Inglés

Eligibility Breast Cancer NCT01425476

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years of age or older
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
increased risk for breast cancer (demonstrated by strong family history [one 1st degree or two 2nd degree relatives], history of dcis, ibc, or precancerous changes in breasts). or gail model risk of developing ibc in a 5-year period of >1.66%
Descripción

Risk Increased Breast Carcinoma | Family history Strong | First Degree Relative Quantity | Second Degree Relative Quantity | DCIS | Inflammatory Breast Carcinoma | Breast changes Precancerous | Gail Risk Model Inflammatory Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1519210
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0007124
UMLS CUI [6]
C0278601
UMLS CUI [7,1]
C0558236
UMLS CUI [7,2]
C1514391
UMLS CUI [8,1]
C1511297
UMLS CUI [8,2]
C0278601
women with a history of breast cancer, must be free of disease and finished with treatment
Descripción

Gender | Breast Carcinoma | Disease Free of | Treatment completed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
UMLS CUI [4]
C0580352
ecog performance status score 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
premenopausal women must not be pregnant.
Descripción

Premenopausal state Pregnancy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of bilateral mastectomy, or bilateral breast irradiation
Descripción

Bilateral mastectomy | Irradiation of breast Bilateral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0191877
UMLS CUI [2,1]
C2148528
UMLS CUI [2,2]
C0238767
significant medical or psychiatric problems making the participant a poor candidate
Descripción

Medical Problem Study Subject Participation Status Poor | Mental problem Study Subject Participation Status Poor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2700379
UMLS CUI [2,1]
C0848067
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2700379
evidence of excess use of narcotics or drug dependency
Descripción

Narcotics Use of Excessive | Drug Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027415
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0442802
UMLS CUI [2]
C1510472
have been pregnant and lactating in the past 2 years
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant history of peptic ulcer disease or upper gastrointestinal bleeding
Descripción

Peptic Ulcer | Upper gastrointestinal hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
history of severe congestive heart failure that requires hospitalization or intervention
Descripción

Congestive heart failure Severe Hospitalization Required | Congestive heart failure Severe Requirement Intervention

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1708385
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0184661
history of asthma requiring medication for treatment
Descripción

Asthma Requirement Pharmacotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
allergy to sulfonamides or nsaid medications
Descripción

Allergy to sulfonamides | Non-steroidal anti-inflammatory drug allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2]
C0570537
history of myocardial infarction or stroke
Descripción

Myocardial Infarction | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
currently on coumadin
Descripción

Coumadin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0699129
currently on tamoxifen (nolvadex),evista (raloxifene), femara (letrozole), arimidex (anastrozole), or aromasin (exemestane)
Descripción

Tamoxifen | Nolvadex | Evista | Raloxifene | Femara | letrozole | Arimidex | anastrozole | Aromasin | exemestane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0919390
UMLS CUI [3]
C0720318
UMLS CUI [4]
C0244404
UMLS CUI [5]
C0701348
UMLS CUI [6]
C0246421
UMLS CUI [7]
C0878174
UMLS CUI [8]
C0290883
UMLS CUI [9]
C0876723
UMLS CUI [10]
C0851344
undergone prior subaeolar breast surgery
Descripción

Operation on breast Subareolar

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0442182
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Similar models

Eligibility Breast Cancer NCT01425476

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Risk Increased Breast Carcinoma | Family history Strong | First Degree Relative Quantity | Second Degree Relative Quantity | DCIS | Inflammatory Breast Carcinoma | Breast changes Precancerous | Gail Risk Model Inflammatory Breast Carcinoma
Item
increased risk for breast cancer (demonstrated by strong family history [one 1st degree or two 2nd degree relatives], history of dcis, ibc, or precancerous changes in breasts). or gail model risk of developing ibc in a 5-year period of >1.66%
boolean
C0035647 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0241889 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1519210 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0007124 (UMLS CUI [5])
C0278601 (UMLS CUI [6])
C0558236 (UMLS CUI [7,1])
C1514391 (UMLS CUI [7,2])
C1511297 (UMLS CUI [8,1])
C0278601 (UMLS CUI [8,2])
Gender | Breast Carcinoma | Disease Free of | Treatment completed
Item
women with a history of breast cancer, must be free of disease and finished with treatment
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0580352 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status score 0-1
boolean
C1520224 (UMLS CUI [1])
Premenopausal state Pregnancy Absent
Item
premenopausal women must not be pregnant.
boolean
C0232969 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Bilateral mastectomy | Irradiation of breast Bilateral
Item
history of bilateral mastectomy, or bilateral breast irradiation
boolean
C0191877 (UMLS CUI [1])
C2148528 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
Medical Problem Study Subject Participation Status Poor | Mental problem Study Subject Participation Status Poor
Item
significant medical or psychiatric problems making the participant a poor candidate
boolean
C1254481 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2700379 (UMLS CUI [1,3])
C0848067 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
Narcotics Use of Excessive | Drug Dependence
Item
evidence of excess use of narcotics or drug dependency
boolean
C0027415 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
C1510472 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
have been pregnant and lactating in the past 2 years
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peptic Ulcer | Upper gastrointestinal hemorrhage
Item
significant history of peptic ulcer disease or upper gastrointestinal bleeding
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
Congestive heart failure Severe Hospitalization Required | Congestive heart failure Severe Requirement Intervention
Item
history of severe congestive heart failure that requires hospitalization or intervention
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
Asthma Requirement Pharmacotherapy
Item
history of asthma requiring medication for treatment
boolean
C0004096 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Allergy to sulfonamides | Non-steroidal anti-inflammatory drug allergy
Item
allergy to sulfonamides or nsaid medications
boolean
C0038757 (UMLS CUI [1])
C0570537 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident
Item
history of myocardial infarction or stroke
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Coumadin
Item
currently on coumadin
boolean
C0699129 (UMLS CUI [1])
Tamoxifen | Nolvadex | Evista | Raloxifene | Femara | letrozole | Arimidex | anastrozole | Aromasin | exemestane
Item
currently on tamoxifen (nolvadex),evista (raloxifene), femara (letrozole), arimidex (anastrozole), or aromasin (exemestane)
boolean
C0039286 (UMLS CUI [1])
C0919390 (UMLS CUI [2])
C0720318 (UMLS CUI [3])
C0244404 (UMLS CUI [4])
C0701348 (UMLS CUI [5])
C0246421 (UMLS CUI [6])
C0878174 (UMLS CUI [7])
C0290883 (UMLS CUI [8])
C0876723 (UMLS CUI [9])
C0851344 (UMLS CUI [10])
Operation on breast Subareolar
Item
undergone prior subaeolar breast surgery
boolean
C3714726 (UMLS CUI [1,1])
C0442182 (UMLS CUI [1,2])
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