ID

39096

Description

Broccoli Sprout Extract in Treating Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01753908

Link

https://clinicaltrials.gov/show/NCT01753908

Keywords

Versions (1)
  1. 12/1/19 12/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Ductal Breast Carcinoma NCT01753908

English

Eligibility Ductal Breast Carcinoma NCT01753908

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal (no menstrual cycle in the past 12 months)
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage i or ii, er positive or negative breast cancer, or ductal carcinoma in situ (dcis)
Description

Carcinoma Incident | Primary Carcinoma | Invasive Carcinoma | Ductal Carcinoma | Carcinoma, Lobular | Carcinoma TNM clinical staging | Oestrogen receptor positive breast cancer | Breast Carcinoma Estrogen receptor negative | DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1551358
UMLS CUI [2]
C1335475
UMLS CUI [3]
C1334274
UMLS CUI [4]
C1176475
UMLS CUI [5]
C0206692
UMLS CUI [6,1]
C0007097
UMLS CUI [6,2]
C3258246
UMLS CUI [7]
C2938924
UMLS CUI [8,1]
C0678222
UMLS CUI [8,2]
C0279756
UMLS CUI [9]
C0007124
no neoadjuvant endocrine therapy or chemotherapy within 12 months
Description

Neoadjuvant Hormone Therapy Absent | Neoadjuvant Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0332197
have an eastern cooperative oncology group (ecog) performance status of =< 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
willing to avoid cruciferous vegetable intake during the study period (2 weeks)
Description

Avoidance Cruciferous vegetables

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0453113
demonstrate the ability to swallow and retain oral medication
Description

Able to swallow Oral medication | Ability Retain Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Description

Comprehension Study Protocol | Comprehension Study Protocol Patient Representative | Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0030701
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
Description

Invasive carcinoma of breast Previous | Mastectomy Previous | irradiation of breast Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0024881
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C2148528
UMLS CUI [3,2]
C0205156
current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
Description

Hormone Therapy Reproductive | Tamoxifen | Aromatase Inhibitors | Estrogen Antagonists Affecting Biomarkers

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0035150
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0593802
UMLS CUI [4,1]
C0014930
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0005516
intolerance to broccoli/itc-bse taste
Description

Intolerance to Broccoli | Intolerance to ITC-BSE

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0330498
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0124209
UMLS CUI [2,3]
C1707048
current ingestion of broccoli sprout extract, which may confound study results
Description

Broccoli sprout extract Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C1707048
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
current or recent treatment for any malignancy within the last one year, which may affect biomarkers
Description

Cancer treatment Affecting Biomarkers

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005516
history of crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
Description

Crohn Disease | Celiac Disease | Malabsorption Syndrome Interferes with Broccoli sprout extract Digestion | Malabsorption Syndrome Interferes with Broccoli sprout extract Absorption

Data type

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0007570
UMLS CUI [3,1]
C0024523
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1707048
UMLS CUI [3,4]
C0012238
UMLS CUI [4,1]
C0024523
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1707048
UMLS CUI [4,4]
C0237442
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Similar models

Eligibility Ductal Breast Carcinoma NCT01753908

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal (no menstrual cycle in the past 12 months)
boolean
C0232970 (UMLS CUI [1])
Carcinoma Incident | Primary Carcinoma | Invasive Carcinoma | Ductal Carcinoma | Carcinoma, Lobular | Carcinoma TNM clinical staging | Oestrogen receptor positive breast cancer | Breast Carcinoma Estrogen receptor negative | DCIS
Item
diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage i or ii, er positive or negative breast cancer, or ductal carcinoma in situ (dcis)
boolean
C0007097 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
C1335475 (UMLS CUI [2])
C1334274 (UMLS CUI [3])
C1176475 (UMLS CUI [4])
C0206692 (UMLS CUI [5])
C0007097 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C2938924 (UMLS CUI [7])
C0678222 (UMLS CUI [8,1])
C0279756 (UMLS CUI [8,2])
C0007124 (UMLS CUI [9])
Neoadjuvant Hormone Therapy Absent | Neoadjuvant Chemotherapy Absent
Item
no neoadjuvant endocrine therapy or chemotherapy within 12 months
boolean
C0600558 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
ECOG performance status
Item
have an eastern cooperative oncology group (ecog) performance status of =< 2
boolean
C1520224 (UMLS CUI [1])
Avoidance Cruciferous vegetables
Item
willing to avoid cruciferous vegetable intake during the study period (2 weeks)
boolean
C0870186 (UMLS CUI [1,1])
C0453113 (UMLS CUI [1,2])
Able to swallow Oral medication | Ability Retain Oral medication
Item
demonstrate the ability to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Comprehension Study Protocol | Comprehension Study Protocol Patient Representative | Informed Consent | Informed Consent Patient Representative
Item
subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Previous | Mastectomy Previous | irradiation of breast Previous
Item
prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C2148528 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Hormone Therapy Reproductive | Tamoxifen | Aromatase Inhibitors | Estrogen Antagonists Affecting Biomarkers
Item
current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
boolean
C0279025 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
C0014930 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0005516 (UMLS CUI [4,3])
Intolerance to Broccoli | Intolerance to ITC-BSE
Item
intolerance to broccoli/itc-bse taste
boolean
C1744706 (UMLS CUI [1,1])
C0330498 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0124209 (UMLS CUI [2,2])
C1707048 (UMLS CUI [2,3])
Broccoli sprout extract Interferes with Research results
Item
current ingestion of broccoli sprout extract, which may confound study results
boolean
C1707048 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Cancer treatment Affecting Biomarkers
Item
current or recent treatment for any malignancy within the last one year, which may affect biomarkers
boolean
C0920425 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
Crohn Disease | Celiac Disease | Malabsorption Syndrome Interferes with Broccoli sprout extract Digestion | Malabsorption Syndrome Interferes with Broccoli sprout extract Absorption
Item
history of crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
boolean
C0010346 (UMLS CUI [1])
C0007570 (UMLS CUI [2])
C0024523 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1707048 (UMLS CUI [3,3])
C0012238 (UMLS CUI [3,4])
C0024523 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1707048 (UMLS CUI [4,3])
C0237442 (UMLS CUI [4,4])
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