ID

38291

Description

Olive Oil for Breast Cancer Prevention in Women at High Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02068092

Link

https://clinicaltrials.gov/show/NCT02068092

Keywords

Versions (1)
  1. 10/8/19 10/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02068092

English

Eligibility Breast Cancer NCT02068092

1 forms  
Criteria
Description

Criteria

2. participants must have an elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:
Description

Risk Elevated Breast Carcinoma | Tamoxifen Refused | Raloxifene Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C3163633
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C1705116
UMLS CUI [3,1]
C0244404
UMLS CUI [3,2]
C1705116
1. diagnosis of lcis, atypical ductal or lobular hyperplasia.
Description

LCIS | Atypical ductal hyperplasia | Atypical lobular hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0279563
UMLS CUI [2]
C0442834
UMLS CUI [3]
C0442835
2. a known deleterious mutation in brca1, brca2, pten or tp53. (note: the participant must be a documented carrier to meet this criterion. if there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per nccn clinical guidelines to be eligible per this criterion.)
Description

Deleterious BRCA1 Gene Mutation | Deleterious BRCA2 Gene Mutation | Deleterious Mutation PTEN gene | Deleterious Mutation TP53 gene

Data type

boolean

Alias
UMLS CUI [1]
C4289700
UMLS CUI [2]
C4287905
UMLS CUI [3,1]
C2985436
UMLS CUI [3,2]
C0694888
UMLS CUI [4,1]
C2985436
UMLS CUI [4,2]
C0079419
3. modified gail/care model risk at 5 years ≥ 1.67%. (note: risk models are to be used only if there is no known previous diagnosis of resected dcis or lcis and there is no known deleterious mutation in brca1, brca2, pten or tp53).
Description

Gail Risk Model Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1511297
UMLS CUI [1,2]
C0439165
4. 10% or more probability of brca mutation by brcapro or similar model
Description

Percentage Probability BRCA gene Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0596223
UMLS CUI [1,4]
C0026882
5. cannot have dcis or previous invasive ductal carcinoma
Description

DCIS Absent | Invasive Ductal Breast Carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0332197
3. participants must have at least one breast available for imaging and biopsy. a previously irradiated breast (i.e., for resected dcis) is not evaluable for breast imaging or biopsy.
Description

Breast Quantity Imaging | Breast Quantity Biopsy | irradiation of breast Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0005558
UMLS CUI [3,1]
C2148528
UMLS CUI [3,2]
C0332196
a. participants must allow submission of core needle breast material (obtained per section 7.3) for future use.
Description

Specimen from breast obtained by core needle biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1292540
4. participants must have a baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that shows either normal or benign findings. participants with mammograms that are reported as suspicious for malignancy are ineligible.
Description

Digital Mammography | Mammography normal | Mammography assessment - Benign finding

Data type

boolean

Alias
UMLS CUI [1]
C0860950
UMLS CUI [2]
C0436449
UMLS CUI [3]
C1301246
5. participants must have baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75%, "extremely dense"). women with a baseline mammographic density of ≤ 10% (1 = ≤10%, breasts are almost entirely fat) will not be eligible
Description

Mammographic Breast Density Percentage Classification | Scattered fibroglandular densities

Data type

boolean

Alias
UMLS CUI [1,1]
C1268717
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0008902
UMLS CUI [2]
C1268645
6. prior tamoxifen or raloxifene use is allowed provided treatment is completed at least 1 year prior to registration
Description

Prior Therapy Completed | Tamoxifen | Raloxifene

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0244404
7. participants must not have bilateral breast implants, but prior breast reduction surgery is allowed. (breast implants are not allowed as they affect density measurements and because of the risk of rupturing the implant with biopsy).
Description

Bilateral breast implant Excluded | Reduction mammaplasty allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C2239094
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0191922
UMLS CUI [2,2]
C0683607
8. participants must have a ecog performance status of 0 - 1 (see section 11).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. for subjects who have taken an anticoagulation within the past 7 days, inr (international normalized ratio) must be ≤ 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ≤ iuln prior to the breast biopsy.
Description

Anticoagulant therapy Discontinued | Status pre- Biopsy of breast | International Normalized Ratio | Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0405352
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0033707
UMLS CUI [5]
C0030605
10. no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
Description

Exclusion Criteria | Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
11. participant must not be pregnant or nursing and must agree to use effective contraception. hormone-based birth control (pills, patches or shots) are allowed, but switching birth control methods is discouraged while on-study as hormonal changes can affect mammographic density. hormone replacement therapy is not allowed for post-menopausal female.
Description

Pregnancy Absent | Breast Feeding Absent | Study Subject Contraceptive methods | Hormonal contraception | Contraceptives, Oral | Contraceptive patch | Shots | Absence Hormone replacement therapy Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0009905
UMLS CUI [6]
C2985284
UMLS CUI [7]
C3842800
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C0282402
UMLS CUI [8,3]
C0232970
12. individuals must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. participants must also agree not to join such a trial while participating in this study.
Description

Exclusion Criteria | Study Subject Participation Status | Cancer treatment | Cancer prevention | Exception Follow-up

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0920425
UMLS CUI [4]
C0281206
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3274571
13. all participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
14. exclude patients with prior tamoxifen and raloxifene use in the past year exclusion criteria
Description

Exclusion Criteria | Prior Therapy Tamoxifen | Prior Therapy Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0039286
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0244404
1. any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
Description

Exclusion Criteria | Malignant Neoplasms Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
2. prior tamoxifen or raloxifene use in the past 1 year
Description

Exclusion Criteria | Prior Therapy Tamoxifen | Prior Therapy Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0039286
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0244404
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Similar models

Eligibility Breast Cancer NCT02068092

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Risk Elevated Breast Carcinoma | Tamoxifen Refused | Raloxifene Refused
Item
2. participants must have an elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:
boolean
C0035647 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0039286 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
C0244404 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
LCIS | Atypical ductal hyperplasia | Atypical lobular hyperplasia
Item
1. diagnosis of lcis, atypical ductal or lobular hyperplasia.
boolean
C0279563 (UMLS CUI [1])
C0442834 (UMLS CUI [2])
C0442835 (UMLS CUI [3])
Deleterious BRCA1 Gene Mutation | Deleterious BRCA2 Gene Mutation | Deleterious Mutation PTEN gene | Deleterious Mutation TP53 gene
Item
2. a known deleterious mutation in brca1, brca2, pten or tp53. (note: the participant must be a documented carrier to meet this criterion. if there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per nccn clinical guidelines to be eligible per this criterion.)
boolean
C4289700 (UMLS CUI [1])
C4287905 (UMLS CUI [2])
C2985436 (UMLS CUI [3,1])
C0694888 (UMLS CUI [3,2])
C2985436 (UMLS CUI [4,1])
C0079419 (UMLS CUI [4,2])
Gail Risk Model Percentage
Item
3. modified gail/care model risk at 5 years ≥ 1.67%. (note: risk models are to be used only if there is no known previous diagnosis of resected dcis or lcis and there is no known deleterious mutation in brca1, brca2, pten or tp53).
boolean
C1511297 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Percentage Probability BRCA gene Mutation
Item
4. 10% or more probability of brca mutation by brcapro or similar model
boolean
C0439165 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0596223 (UMLS CUI [1,3])
C0026882 (UMLS CUI [1,4])
DCIS Absent | Invasive Ductal Breast Carcinoma Absent
Item
5. cannot have dcis or previous invasive ductal carcinoma
boolean
C0007124 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1134719 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Breast Quantity Imaging | Breast Quantity Biopsy | irradiation of breast Excluded
Item
3. participants must have at least one breast available for imaging and biopsy. a previously irradiated breast (i.e., for resected dcis) is not evaluable for breast imaging or biopsy.
boolean
C0006141 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0006141 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C2148528 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Specimen from breast obtained by core needle biopsy
Item
a. participants must allow submission of core needle breast material (obtained per section 7.3) for future use.
boolean
C1292540 (UMLS CUI [1])
Digital Mammography | Mammography normal | Mammography assessment - Benign finding
Item
4. participants must have a baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that shows either normal or benign findings. participants with mammograms that are reported as suspicious for malignancy are ineligible.
boolean
C0860950 (UMLS CUI [1])
C0436449 (UMLS CUI [2])
C1301246 (UMLS CUI [3])
Mammographic Breast Density Percentage Classification | Scattered fibroglandular densities
Item
5. participants must have baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75%, "extremely dense"). women with a baseline mammographic density of ≤ 10% (1 = ≤10%, breasts are almost entirely fat) will not be eligible
boolean
C1268717 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C1268645 (UMLS CUI [2])
Prior Therapy Completed | Tamoxifen | Raloxifene
Item
6. prior tamoxifen or raloxifene use is allowed provided treatment is completed at least 1 year prior to registration
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
C0244404 (UMLS CUI [3])
Bilateral breast implant Excluded | Reduction mammaplasty allowed
Item
7. participants must not have bilateral breast implants, but prior breast reduction surgery is allowed. (breast implants are not allowed as they affect density measurements and because of the risk of rupturing the implant with biopsy).
boolean
C2239094 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0191922 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
ECOG performance status
Item
8. participants must have a ecog performance status of 0 - 1 (see section 11).
boolean
C1520224 (UMLS CUI [1])
Anticoagulant therapy Discontinued | Status pre- Biopsy of breast | International Normalized Ratio | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
9. prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. for subjects who have taken an anticoagulation within the past 7 days, inr (international normalized ratio) must be ≤ 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ≤ iuln prior to the breast biopsy.
boolean
C0150457 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0405352 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])
C0033707 (UMLS CUI [4])
C0030605 (UMLS CUI [5])
Exclusion Criteria | Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
10. no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
boolean
C0680251 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Pregnancy Absent | Breast Feeding Absent | Study Subject Contraceptive methods | Hormonal contraception | Contraceptives, Oral | Contraceptive patch | Shots | Absence Hormone replacement therapy Postmenopausal state
Item
11. participant must not be pregnant or nursing and must agree to use effective contraception. hormone-based birth control (pills, patches or shots) are allowed, but switching birth control methods is discouraged while on-study as hormonal changes can affect mammographic density. hormone replacement therapy is not allowed for post-menopausal female.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C2985284 (UMLS CUI [6])
C3842800 (UMLS CUI [7])
C0332197 (UMLS CUI [8,1])
C0282402 (UMLS CUI [8,2])
C0232970 (UMLS CUI [8,3])
Exclusion Criteria | Study Subject Participation Status | Cancer treatment | Cancer prevention | Exception Follow-up
Item
12. individuals must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. participants must also agree not to join such a trial while participating in this study.
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
C0281206 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C3274571 (UMLS CUI [5,2])
Informed Consent
Item
13. all participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria | Prior Therapy Tamoxifen | Prior Therapy Raloxifene
Item
14. exclude patients with prior tamoxifen and raloxifene use in the past year exclusion criteria
boolean
C0680251 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0039286 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0244404 (UMLS CUI [3,2])
Exclusion Criteria | Malignant Neoplasms Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
1. any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
boolean
C0680251 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Exclusion Criteria | Prior Therapy Tamoxifen | Prior Therapy Raloxifene
Item
2. prior tamoxifen or raloxifene use in the past 1 year
boolean
C0680251 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0039286 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0244404 (UMLS CUI [3,2])
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