ID

39095

Beschrijving

Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01869764

Link

https://clinicaltrials.gov/show/NCT01869764

Trefwoorden

Versies (1)
  1. 01-12-19 01-12-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 december 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Ductal Breast Carcinoma in Situ NCT01869764

Engels

Eligibility Ductal Breast Carcinoma in Situ NCT01869764

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed stage i to iii breast cancer and carcinoma in situ (including lobular carcinoma in situ [lcis] and ductal carcinoma in situ [dcis])
Beschrijving

Breast Carcinoma TNM Breast tumor staging | Carcinoma in Situ TNM Breast tumor staging | LCIS TNM Breast tumor staging | DCIS TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0007099
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C0279563
UMLS CUI [3,2]
C0474926
UMLS CUI [4,1]
C0007124
UMLS CUI [4,2]
C0474926
breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Beschrijving

Operation on breast Planned | Segmental Mastectomy Planned | Mastectomy Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0024885
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0024881
UMLS CUI [3,2]
C1301732
ability to understand and the willingness to sign an institutional review board (irb)-approved written informed consent document
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
tumor measures at least 1 centimeter on imaging or physical exam
Beschrijving

Tumor size Imaging | Tumor size Physical Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0031809
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any patient with surgery scheduled < 7days after biopsy
Beschrijving

Patient scheduled for surgery | Status post Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C3242215
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0005558
patients who are unable to refrain from the use of any nsaid or full-dose acetylsalicylic acid (asa)-containing nsaid while taking study drug
Beschrijving

Discontinue NSAIDs Unable | Discontinue Aspirin Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0003211
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1444662
UMLS CUI [2,2]
C0004057
UMLS CUI [2,3]
C1299582
patients who will receive neoadjuvant chemotherapy are not eligible
Beschrijving

Neoadjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
Beschrijving

Omega-3 Fatty Acids

Datatype

boolean

Alias
UMLS CUI [1]
C0015689
patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
Beschrijving

Omega-3 Fatty Acids Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0205156
patients with an allergy or known hypersensitivity to fish
Beschrijving

Allergy to fish

Datatype

boolean

Alias
UMLS CUI [1]
C0856904
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Similar models

Eligibility Ductal Breast Carcinoma in Situ NCT01869764

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Carcinoma in Situ TNM Breast tumor staging | LCIS TNM Breast tumor staging | DCIS TNM Breast tumor staging
Item
newly diagnosed stage i to iii breast cancer and carcinoma in situ (including lobular carcinoma in situ [lcis] and ductal carcinoma in situ [dcis])
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007099 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0279563 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0007124 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
Operation on breast Planned | Segmental Mastectomy Planned | Mastectomy Planned
Item
breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
boolean
C3714726 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0024881 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Informed Consent
Item
ability to understand and the willingness to sign an institutional review board (irb)-approved written informed consent document
boolean
C0021430 (UMLS CUI [1])
Tumor size Imaging | Tumor size Physical Examination
Item
tumor measures at least 1 centimeter on imaging or physical exam
boolean
C0475440 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patient scheduled for surgery | Status post Biopsy
Item
any patient with surgery scheduled < 7days after biopsy
boolean
C3242215 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Discontinue NSAIDs Unable | Discontinue Aspirin Unable
Item
patients who are unable to refrain from the use of any nsaid or full-dose acetylsalicylic acid (asa)-containing nsaid while taking study drug
boolean
C1444662 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1444662 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Neoadjuvant Chemotherapy
Item
patients who will receive neoadjuvant chemotherapy are not eligible
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Omega-3 Fatty Acids
Item
patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
boolean
C0015689 (UMLS CUI [1])
Omega-3 Fatty Acids Previous
Item
patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
boolean
C0015689 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Allergy to fish
Item
patients with an allergy or known hypersensitivity to fish
boolean
C0856904 (UMLS CUI [1])
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