ID

27028

Description

Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue; ODM derived from: https://clinicaltrials.gov/show/NCT00982319

Link

https://clinicaltrials.gov/show/NCT00982319

Keywords

Versions (1)
  1. 10/29/17 10/29/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00982319

English

Eligibility Breast Cancer NCT00982319

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female 18 + years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
confirmed diagnosis of dcis on core or excisional/incisional biopsy and scheduled for definitive surgery
Description

DCIS Core needle biopsy | DCIS Excision biopsy | DCIS Incisional biopsy | Operative Surgical Procedures Definitive Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C0184921
UMLS CUI [3,1]
C0007124
UMLS CUI [3,2]
C0184922
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0443196
UMLS CUI [4,3]
C0205539
pre or post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
Description

Premenopausal state | Postmenopausal state | Hormone replacement therapy Absent | Tamoxifen Absent | Raloxifene Absent

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0039286
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0244404
UMLS CUI [5,2]
C0332197
agree to avoid cruciferous vegetable/condiment intake for 14 days
Description

Avoidance Cruciferous vegetable -

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0453113
agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes
Description

Informed Consent | Biopsy Tissue specimen Availabile | Operative Surgical Procedures Tissue specimen Available | Research Purpose

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1292533
UMLS CUI [2,3]
C0470187
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1292533
UMLS CUI [3,3]
C0470187
UMLS CUI [4,1]
C0035168
UMLS CUI [4,2]
C1285529
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
Description

Hormone replacement therapy | Tamoxifen | Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0244404
used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
Description

Antibiotics | Diet Cruciferous vegetables Free of

Data type

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0453113
UMLS CUI [2,3]
C0332296
smoked within the past 12 months prior to eligibility screening;
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
active infection or inflammation of the breast at time of eligibility screening
Description

Breast infection | Inflammatory disorder of breast

Data type

boolean

Alias
UMLS CUI [1]
C0392317
UMLS CUI [2]
C3495439
has baseline comprehensive metabolic panel (cmp) [glucose, calcium, albumin, serum total protein (tp), sodium, potassium, carbon dioxide, chloride, blood urea nitrogen (bun), creatinine, alkaline phosphatase (alp), alanine amino transferase (ast), aspartate amino transferase (sgot), and bilirubin], prothrombin time (pt) and , complete blood count (cbc) values that are 1.5 times in either direction the reported normal range
Description

Comprehensive metabolic panel | Glucose measurement | Calcium measurement | Albumin measurement | Serum total protein measurement | Sodium measurement | Potassium measurement | Carbon dioxide measurement | Chloride measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Prothrombin time assay | Complete Blood Count

Data type

boolean

Alias
UMLS CUI [1]
C0519825
UMLS CUI [2]
C0337438
UMLS CUI [3]
C0201925
UMLS CUI [4]
C0201838
UMLS CUI [5]
C0036836
UMLS CUI [6]
C0337443
UMLS CUI [7]
C0202194
UMLS CUI [8]
C0201930
UMLS CUI [9]
C0201952
UMLS CUI [10]
C0005845
UMLS CUI [11]
C0201976
UMLS CUI [12]
C0201850
UMLS CUI [13]
C0201836
UMLS CUI [14]
C0201899
UMLS CUI [15]
C1278039
UMLS CUI [16]
C0033707
UMLS CUI [17]
C0009555
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Similar models

Eligibility Breast Cancer NCT00982319

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female 18 + years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
DCIS Core needle biopsy | DCIS Excision biopsy | DCIS Incisional biopsy | Operative Surgical Procedures Definitive Scheduled
Item
confirmed diagnosis of dcis on core or excisional/incisional biopsy and scheduled for definitive surgery
boolean
C0007124 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2,1])
C0184921 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3,1])
C0184922 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0443196 (UMLS CUI [4,2])
C0205539 (UMLS CUI [4,3])
Premenopausal state | Postmenopausal state | Hormone replacement therapy Absent | Tamoxifen Absent | Raloxifene Absent
Item
pre or post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0282402 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0244404 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Avoidance Cruciferous vegetable -
Item
agree to avoid cruciferous vegetable/condiment intake for 14 days
boolean
C0870186 (UMLS CUI [1,1])
C0453113 (UMLS CUI [1,2])
Informed Consent | Biopsy Tissue specimen Availabile | Operative Surgical Procedures Tissue specimen Available | Research Purpose
Item
agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes
boolean
C0021430 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1292533 (UMLS CUI [3,2])
C0470187 (UMLS CUI [3,3])
C0035168 (UMLS CUI [4,1])
C1285529 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Hormone replacement therapy | Tamoxifen | Raloxifene
Item
used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
boolean
C0282402 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0244404 (UMLS CUI [3])
Antibiotics | Diet Cruciferous vegetables Free of
Item
used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
boolean
C0003232 (UMLS CUI [1])
C0012159 (UMLS CUI [2,1])
C0453113 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Tobacco use
Item
smoked within the past 12 months prior to eligibility screening;
boolean
C0543414 (UMLS CUI [1])
Breast infection | Inflammatory disorder of breast
Item
active infection or inflammation of the breast at time of eligibility screening
boolean
C0392317 (UMLS CUI [1])
C3495439 (UMLS CUI [2])
Comprehensive metabolic panel | Glucose measurement | Calcium measurement | Albumin measurement | Serum total protein measurement | Sodium measurement | Potassium measurement | Carbon dioxide measurement | Chloride measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Prothrombin time assay | Complete Blood Count
Item
has baseline comprehensive metabolic panel (cmp) [glucose, calcium, albumin, serum total protein (tp), sodium, potassium, carbon dioxide, chloride, blood urea nitrogen (bun), creatinine, alkaline phosphatase (alp), alanine amino transferase (ast), aspartate amino transferase (sgot), and bilirubin], prothrombin time (pt) and , complete blood count (cbc) values that are 1.5 times in either direction the reported normal range
boolean
C0519825 (UMLS CUI [1])
C0337438 (UMLS CUI [2])
C0201925 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C0036836 (UMLS CUI [5])
C0337443 (UMLS CUI [6])
C0202194 (UMLS CUI [7])
C0201930 (UMLS CUI [8])
C0201952 (UMLS CUI [9])
C0005845 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
C0201850 (UMLS CUI [12])
C0201836 (UMLS CUI [13])
C0201899 (UMLS CUI [14])
C1278039 (UMLS CUI [15])
C0033707 (UMLS CUI [16])
C0009555 (UMLS CUI [17])
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