ID

26610

Beskrivning

Vitamin D in Postmenopausal Women at High Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00859651

Länk

https://clinicaltrials.gov/show/NCT00859651

Nyckelord

Versioner (1)
  1. 2017-10-22 2017-10-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00859651

Engelsk

Eligibility Breast Cancer NCT00859651

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
elevated risk of breast cancer defined as having at least one of the following: (1) predicted 5-year modified gail model risk of 1.67% or greater, (2) lobular carcinoma in situ, (3) known brca1 or brca2 deleterious mutation carrier, (4) prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.
Beskrivning

Risk Elevated Breast Carcinoma | Gail Risk Model | Lobular carcinoma in situ of breast | BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious | Noninfiltrating Intraductal Carcinoma | Tamoxifen Absent | Absence Therapeutic radiology procedure Breast Contralateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C3163633
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C1511297
UMLS CUI [3]
C0279563
UMLS CUI [4,1]
C3899965
UMLS CUI [4,2]
C2985436
UMLS CUI [5,1]
C3899964
UMLS CUI [5,2]
C2985436
UMLS CUI [6]
C0007124
UMLS CUI [7,1]
C0039286
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C1522449
UMLS CUI [8,3]
C0006141
UMLS CUI [8,4]
C0441988
age 21 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophrectomy, or serum fsh/lh values consistent with institutional normal values for the postmenopausal state.
Beskrivning

Postmenopausal state | Bilateral oophorectomy | Serum FSH Test Adequate | Serum LH measurement Adequate

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0278321
UMLS CUI [3,1]
C1254696
UMLS CUI [3,2]
C0205411
UMLS CUI [4,1]
C1304771
UMLS CUI [4,2]
C0205411
baseline mammographic density ≥25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").
Beskrivning

Mammographic breast density Assessment | Scattered fibroglandular densities | Heterogeneously dense breast composition | Extremely dense breast composition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1268717
UMLS CUI [1,2]
C1516048
UMLS CUI [2]
C1268645
UMLS CUI [3]
C1268646
UMLS CUI [4]
C1268647
baseline serum 25-hydroxyvitamin d <32 ng/ml.
Beskrivning

serum 25-hydroxyvitamin D measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C2229552
normal breast exam and mammogram (birads score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. normal baseline breast mri (birads score of 1, 2, or 3).
Beskrivning

Physical breast examination normal | Mammogram normal | BI-RADS | Diagnostic imaging breast abnormal | BREAST BIOPSY BENIGN | Breast Carcinoma Absent | Magnetic resonance imaging breast normal

Datatyp

boolean

Alias
UMLS CUI [1]
C1096032
UMLS CUI [2]
C0740311
UMLS CUI [3]
C1511314
UMLS CUI [4]
C1386870
UMLS CUI [5]
C0741653
UMLS CUI [6,1]
C0678222
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C2939043
prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
Beskrivning

Tamoxifen Discontinued | Raloxifene Discontinued

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0244404
UMLS CUI [2,2]
C1444662
at least one breast available for imaging. no bilateral breast implants.
Beskrivning

Breast Quantity Available Imaging | Bilateral breast implant Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0470187
UMLS CUI [1,4]
C0011923
UMLS CUI [2,1]
C2239094
UMLS CUI [2,2]
C0332197
willingness to not take vitamin d supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.
Beskrivning

Vitamin D supplement Avoidance Willing | Calcium supplementation Dosage allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C1096745
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0683607
normal serum calcium.
Beskrivning

Serum calcium normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0858094
adequate renal and hepatic function: serum creatinine, bilirubin, ast, alt and alkaline phosphatase < 2.0 x the institutional upper limit of normal (iuln).
Beskrivning

Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
zubrod performance status of 0 or 1.
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other prior malignancy. the following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception TNM clinical staging In complete remission | Exception Other Cancer Disease Free of | Exception Breast Carcinoma Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3258246
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1707251
UMLS CUI [6,3]
C0012634
UMLS CUI [6,4]
C0332296
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0678222
UMLS CUI [7,3]
C0012634
UMLS CUI [7,4]
C0332296
history of kidney stones.
Beskrivning

Kidney Calculi

Datatyp

boolean

Alias
UMLS CUI [1]
C0022650
hypersensitivity reactions to vitamin d.
Beskrivning

Vitamin D allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571828
on estrogen replacement therapy.
Beskrivning

Estrogen Replacement Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014935
significant medical or psychiatric condition that would preclude study completion.
Beskrivning

Medical condition Excludes Completion of clinical trial | Mental disorders Exclude Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2732579
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Similar models

Eligibility Breast Cancer NCT00859651

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Risk Elevated Breast Carcinoma | Gail Risk Model | Lobular carcinoma in situ of breast | BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious | Noninfiltrating Intraductal Carcinoma | Tamoxifen Absent | Absence Therapeutic radiology procedure Breast Contralateral
Item
elevated risk of breast cancer defined as having at least one of the following: (1) predicted 5-year modified gail model risk of 1.67% or greater, (2) lobular carcinoma in situ, (3) known brca1 or brca2 deleterious mutation carrier, (4) prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.
boolean
C0035647 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1511297 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
C3899965 (UMLS CUI [4,1])
C2985436 (UMLS CUI [4,2])
C3899964 (UMLS CUI [5,1])
C2985436 (UMLS CUI [5,2])
C0007124 (UMLS CUI [6])
C0039286 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0332197 (UMLS CUI [8,1])
C1522449 (UMLS CUI [8,2])
C0006141 (UMLS CUI [8,3])
C0441988 (UMLS CUI [8,4])
Age
Item
age 21 years or older.
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Bilateral oophorectomy | Serum FSH Test Adequate | Serum LH measurement Adequate
Item
postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophrectomy, or serum fsh/lh values consistent with institutional normal values for the postmenopausal state.
boolean
C0232970 (UMLS CUI [1])
C0278321 (UMLS CUI [2])
C1254696 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C1304771 (UMLS CUI [4,1])
C0205411 (UMLS CUI [4,2])
Mammographic breast density Assessment | Scattered fibroglandular densities | Heterogeneously dense breast composition | Extremely dense breast composition
Item
baseline mammographic density ≥25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").
boolean
C1268717 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1268645 (UMLS CUI [2])
C1268646 (UMLS CUI [3])
C1268647 (UMLS CUI [4])
serum 25-hydroxyvitamin D measurement
Item
baseline serum 25-hydroxyvitamin d <32 ng/ml.
boolean
C2229552 (UMLS CUI [1])
Physical breast examination normal | Mammogram normal | BI-RADS | Diagnostic imaging breast abnormal | BREAST BIOPSY BENIGN | Breast Carcinoma Absent | Magnetic resonance imaging breast normal
Item
normal breast exam and mammogram (birads score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. normal baseline breast mri (birads score of 1, 2, or 3).
boolean
C1096032 (UMLS CUI [1])
C0740311 (UMLS CUI [2])
C1511314 (UMLS CUI [3])
C1386870 (UMLS CUI [4])
C0741653 (UMLS CUI [5])
C0678222 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C2939043 (UMLS CUI [7])
Tamoxifen Discontinued | Raloxifene Discontinued
Item
prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
boolean
C0039286 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0244404 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Breast Quantity Available Imaging | Bilateral breast implant Absent
Item
at least one breast available for imaging. no bilateral breast implants.
boolean
C0006141 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
C2239094 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Vitamin D supplement Avoidance Willing | Calcium supplementation Dosage allowed
Item
willingness to not take vitamin d supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.
boolean
C3541352 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1096745 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Serum calcium normal
Item
normal serum calcium.
boolean
C0858094 (UMLS CUI [1])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate renal and hepatic function: serum creatinine, bilirubin, ast, alt and alkaline phosphatase < 2.0 x the institutional upper limit of normal (iuln).
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Zubrod Performance Status
Item
zubrod performance status of 0 or 1.
boolean
C3714786 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception TNM clinical staging In complete remission | Exception Other Cancer Disease Free of | Exception Breast Carcinoma Disease Free of
Item
other prior malignancy. the following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0332296 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
C0012634 (UMLS CUI [7,3])
C0332296 (UMLS CUI [7,4])
Kidney Calculi
Item
history of kidney stones.
boolean
C0022650 (UMLS CUI [1])
Vitamin D allergy
Item
hypersensitivity reactions to vitamin d.
boolean
C0571828 (UMLS CUI [1])
Estrogen Replacement Therapy
Item
on estrogen replacement therapy.
boolean
C0014935 (UMLS CUI [1])
Medical condition Excludes Completion of clinical trial | Mental disorders Exclude Completion of clinical trial
Item
significant medical or psychiatric condition that would preclude study completion.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
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