ID

35005

Beschrijving

Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT02295059

Link

https://clinicaltrials.gov/show/NCT02295059

Trefwoorden

Versies (1)
  1. 08-02-19 08-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02295059

Engels

Eligibility Breast Cancer NCT02295059

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior diagnosis of stage 0 to iii breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy.
Beschrijving

Breast Carcinoma Estrogen receptor negative TNM Breast tumor staging | Breast Carcinoma Progesterone receptor negative TNM Breast tumor staging | Operative Surgical Procedures Completion | Therapeutic radiology procedure Completion | Chemotherapy Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279756
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279766
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205197
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0205197
completion of chemotherapy or trastuzumab for > six months and of radiation therapy for > 2 months, as applicable and 2 years or less from completion of standard therapy.
Beschrijving

Chemotherapy Completion | Trastuzumab Completion | Therapeutic radiology procedure Completion | Standard of Care Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0205197
greater than 1 year from pregnancy, lactation.
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
mammogram within the six months prior to study enrollment that is not suspicious for breast cancer (acr class i-iii).
Beschrijving

Mammography | Absence Suspicion Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0024671
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0242114
UMLS CUI [2,3]
C0678222
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
other current malignancy or metastatic malignancy of any kind.
Beschrijving

Cancer Other | Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0027627
ongoing chemotherapy, radiation therapy, or other cancer-related treatment.
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0920425
subjects on coumadin or other anticoagulants.
Beschrijving

Coumadin | Anticoagulants

Datatype

boolean

Alias
UMLS CUI [1]
C0699129
UMLS CUI [2]
C0003280
subjects with breast implants.
Beschrijving

Breast implants

Datatype

boolean

Alias
UMLS CUI [1]
C0179412
subjects who have had radiation to both breasts or who have undergone bilateral mastectomies.
Beschrijving

Therapeutic radiology procedure Both breasts | Bilateral mastectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0222605
UMLS CUI [2]
C0191877
barriers to fine needle aspiration sampling of breast adipose tissue and/or parenchymal breast tissue, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose/parenchymal tissue for adequate fine needle aspiration (fna) sampling.
Beschrijving

BARRIER Fine needle aspiration Sampling Fatty tissue of breast | BARRIER Fine needle aspiration Sampling Parenchymal Tissue Breast | Breast implants | Therapeutic radiology procedure Both breasts | Bilateral mastectomy | Fatty tissue of breast Insufficient Fine needle aspiration Sampling | Parenchymal Tissue Breast Insufficient Fine needle aspiration Sampling

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706912
UMLS CUI [1,2]
C1510483
UMLS CUI [1,3]
C0441621
UMLS CUI [1,4]
C1305788
UMLS CUI [2,1]
C1706912
UMLS CUI [2,2]
C1510483
UMLS CUI [2,3]
C0441621
UMLS CUI [2,4]
C4277702
UMLS CUI [2,5]
C0006141
UMLS CUI [3]
C0179412
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0222605
UMLS CUI [5]
C0191877
UMLS CUI [6,1]
C1305788
UMLS CUI [6,2]
C0231180
UMLS CUI [6,3]
C1510483
UMLS CUI [6,4]
C0441621
UMLS CUI [7,1]
C4277702
UMLS CUI [7,2]
C0006141
UMLS CUI [7,3]
C0231180
UMLS CUI [7,4]
C1510483
UMLS CUI [7,5]
C0441621
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements.
Beschrijving

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Hypertensive disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0020538
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
chronic use of omega 3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega 3 fatty acid supplements.
Beschrijving

Omega-3 Fatty Acids chronic | Supplements Interaction Omega-3 Fatty Acid Supplements

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0687133
UMLS CUI [2,3]
C0015689
UMLS CUI [2,4]
C0242295
pregnant or nursing women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known sensitivity or allergy to fish.
Beschrijving

Allergy to fish

Datatype

boolean

Alias
UMLS CUI [1]
C0856904
subjects on a standing regimen of full dose aspirin (greater than 325 mg/day), nsaids or nsaid-containing products.
Beschrijving

Aspirin Dose Full U/day | Anti-Inflammatory Agents, Non-Steroidal | Product Containing NSAIDs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [1,4]
C0456683
UMLS CUI [2]
C0003211
UMLS CUI [3,1]
C1514468
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0003211
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Similar models

Eligibility Breast Cancer NCT02295059

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Estrogen receptor negative TNM Breast tumor staging | Breast Carcinoma Progesterone receptor negative TNM Breast tumor staging | Operative Surgical Procedures Completion | Therapeutic radiology procedure Completion | Chemotherapy Completion
Item
prior diagnosis of stage 0 to iii breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy.
boolean
C0678222 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0279766 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Chemotherapy Completion | Trastuzumab Completion | Therapeutic radiology procedure Completion | Standard of Care Completion
Item
completion of chemotherapy or trastuzumab for > six months and of radiation therapy for > 2 months, as applicable and 2 years or less from completion of standard therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Pregnancy Absent | Breast Feeding Absent
Item
greater than 1 year from pregnancy, lactation.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Mammography | Absence Suspicion Breast Carcinoma
Item
mammogram within the six months prior to study enrollment that is not suspicious for breast cancer (acr class i-iii).
boolean
C0024671 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Neoplasm Metastasis
Item
other current malignancy or metastatic malignancy of any kind.
boolean
C1707251 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Cancer treatment
Item
ongoing chemotherapy, radiation therapy, or other cancer-related treatment.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
Coumadin | Anticoagulants
Item
subjects on coumadin or other anticoagulants.
boolean
C0699129 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
Breast implants
Item
subjects with breast implants.
boolean
C0179412 (UMLS CUI [1])
Therapeutic radiology procedure Both breasts | Bilateral mastectomy
Item
subjects who have had radiation to both breasts or who have undergone bilateral mastectomies.
boolean
C1522449 (UMLS CUI [1,1])
C0222605 (UMLS CUI [1,2])
C0191877 (UMLS CUI [2])
BARRIER Fine needle aspiration Sampling Fatty tissue of breast | BARRIER Fine needle aspiration Sampling Parenchymal Tissue Breast | Breast implants | Therapeutic radiology procedure Both breasts | Bilateral mastectomy | Fatty tissue of breast Insufficient Fine needle aspiration Sampling | Parenchymal Tissue Breast Insufficient Fine needle aspiration Sampling
Item
barriers to fine needle aspiration sampling of breast adipose tissue and/or parenchymal breast tissue, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose/parenchymal tissue for adequate fine needle aspiration (fna) sampling.
boolean
C1706912 (UMLS CUI [1,1])
C1510483 (UMLS CUI [1,2])
C0441621 (UMLS CUI [1,3])
C1305788 (UMLS CUI [1,4])
C1706912 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C0441621 (UMLS CUI [2,3])
C4277702 (UMLS CUI [2,4])
C0006141 (UMLS CUI [2,5])
C0179412 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0222605 (UMLS CUI [4,2])
C0191877 (UMLS CUI [5])
C1305788 (UMLS CUI [6,1])
C0231180 (UMLS CUI [6,2])
C1510483 (UMLS CUI [6,3])
C0441621 (UMLS CUI [6,4])
C4277702 (UMLS CUI [7,1])
C0006141 (UMLS CUI [7,2])
C0231180 (UMLS CUI [7,3])
C1510483 (UMLS CUI [7,4])
C0441621 (UMLS CUI [7,5])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Hypertensive disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0020538 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Omega-3 Fatty Acids chronic | Supplements Interaction Omega-3 Fatty Acid Supplements
Item
chronic use of omega 3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega 3 fatty acid supplements.
boolean
C0015689 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0015689 (UMLS CUI [2,3])
C0242295 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergy to fish
Item
known sensitivity or allergy to fish.
boolean
C0856904 (UMLS CUI [1])
Aspirin Dose Full U/day | Anti-Inflammatory Agents, Non-Steroidal | Product Containing NSAIDs
Item
subjects on a standing regimen of full dose aspirin (greater than 325 mg/day), nsaids or nsaid-containing products.
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2])
C1514468 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0003211 (UMLS CUI [3,3])
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