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ID

38320

Description

Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01257152

Link

https://clinicaltrials.gov/show/NCT01257152

Keywords

Versions (1)
  1. 10/10/19 10/10/19 -
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See clinicaltrials.gov

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October 10, 2019

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Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT01257152

    English

    Eligibility Breast Neoplasms NCT01257152

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    women ≥ 20 years in age;
    Description

    Gender | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
    Description

    Gender | Breast-Conserving Surgery Invasive carcinoma of breast | Negative Surgical Margin | Therapeutic radiology procedure Completed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0917927
    UMLS CUI [2,2]
    C0853879
    UMLS CUI [3]
    C1709157
    UMLS CUI [4,1]
    C1522449
    UMLS CUI [4,2]
    C0205197
    no history of breast biopsy of the breast within 6 months prior to this study;
    Description

    Biopsy of breast Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0405352
    UMLS CUI [1,2]
    C0332197
    signed study-specific informed consent prior to registration;
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    has not had contralateral mastectomy;
    Description

    Mastectomy Contralateral Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024881
    UMLS CUI [1,2]
    C0441988
    UMLS CUI [1,3]
    C0332197
    no known metastatic disease;
    Description

    Neoplasm Metastasis Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C0332197
    not pregnant or lactating;
    Description

    Pregnancy Absent | Breast Feeding Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0006147
    UMLS CUI [2,2]
    C0332197
    no present signs or symptoms of breast cancer [no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)].
    Description

    Sign or Symptom Absent Breast Carcinoma | Breast Palpable mass Absent | No nipple discharge | Bleeding from nipple Absent | Mass of axilla Absent | Absence Breast skin change Abnormal | Absence Nipples skin change Abnormal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3540840
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0678222
    UMLS CUI [2,1]
    C1403543
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3]
    C0425813
    UMLS CUI [4,1]
    C0281789
    UMLS CUI [4,2]
    C0332197
    UMLS CUI [5,1]
    C0238729
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [6,1]
    C0332197
    UMLS CUI [6,2]
    C0006141
    UMLS CUI [6,3]
    C1399787
    UMLS CUI [6,4]
    C0205161
    UMLS CUI [7,1]
    C0332197
    UMLS CUI [7,2]
    C0028109
    UMLS CUI [7,3]
    C1399787
    UMLS CUI [7,4]
    C0205161
    no contraindications to mri examination.
    Description

    Medical contraindication Absent MRI

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0024485
    no prior mri, us or mammography within the 6 months prior to the study.
    Description

    MRI Absent | Ultrasonography Absent | Mammography Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0041618
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0024671
    UMLS CUI [3,2]
    C0332197
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    had a screening contrast-enhanced breast mri within the past 24 months or diagnostic contrast-enhanced mri on any study breasts within the past 12 months;
    Description

    Contrast-enhanced MRI Breast

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707501
    UMLS CUI [1,2]
    C0006141
    had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
    Description

    Operation on breast | Core biopsy of breast

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714726
    UMLS CUI [2]
    C0842740
    currently receiving chemotherapy [with exception to participant with personal history of cancer, and on chemoprevention with tamoxifen, evista (raloxifene), arimidex (anastrozole), aromasin (exemestane) or other aromatase inhibitor];
    Description

    Chemotherapy | Exception Individual Cancer History | Exception Chemoprevention Tamoxifen | Exception Evista | Exception Raloxifene | Exception Arimidex | Exception Anastrozole | Exception Aromasin | Exception Exemestane | Exception Aromatase Inhibitors

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1512706
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0282515
    UMLS CUI [3,3]
    C0039286
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0720318
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0244404
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0878174
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0290883
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0876723
    UMLS CUI [9,1]
    C1705847
    UMLS CUI [9,2]
    C0851344
    UMLS CUI [10,1]
    C1705847
    UMLS CUI [10,2]
    C0593802
    participant with severely impaired renal function with estimated glomerular filtration rate (gfr) < 30 ml/min/1.73m2 and/or on dialysis.
    Description

    Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1565489
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C3811844
    UMLS CUI [3]
    C0011946
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    Similar models

    Eligibility Breast Neoplasms NCT01257152

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Age
    Item
    women ≥ 20 years in age;
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Gender | Breast-Conserving Surgery Invasive carcinoma of breast | Negative Surgical Margin | Therapeutic radiology procedure Completed
    Item
    women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
    boolean
    C0079399 (UMLS CUI [1])
    C0917927 (UMLS CUI [2,1])
    C0853879 (UMLS CUI [2,2])
    C1709157 (UMLS CUI [3])
    C1522449 (UMLS CUI [4,1])
    C0205197 (UMLS CUI [4,2])
    Biopsy of breast Absent
    Item
    no history of breast biopsy of the breast within 6 months prior to this study;
    boolean
    C0405352 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Informed Consent
    Item
    signed study-specific informed consent prior to registration;
    boolean
    C0021430 (UMLS CUI [1])
    Mastectomy Contralateral Absent
    Item
    has not had contralateral mastectomy;
    boolean
    C0024881 (UMLS CUI [1,1])
    C0441988 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    Neoplasm Metastasis Absent
    Item
    no known metastatic disease;
    boolean
    C0027627 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Pregnancy Absent | Breast Feeding Absent
    Item
    not pregnant or lactating;
    boolean
    C0032961 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Sign or Symptom Absent Breast Carcinoma | Breast Palpable mass Absent | No nipple discharge | Bleeding from nipple Absent | Mass of axilla Absent | Absence Breast skin change Abnormal | Absence Nipples skin change Abnormal
    Item
    no present signs or symptoms of breast cancer [no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)].
    boolean
    C3540840 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [1,3])
    C1403543 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0425813 (UMLS CUI [3])
    C0281789 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    C0238729 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0332197 (UMLS CUI [6,1])
    C0006141 (UMLS CUI [6,2])
    C1399787 (UMLS CUI [6,3])
    C0205161 (UMLS CUI [6,4])
    C0332197 (UMLS CUI [7,1])
    C0028109 (UMLS CUI [7,2])
    C1399787 (UMLS CUI [7,3])
    C0205161 (UMLS CUI [7,4])
    Medical contraindication Absent MRI
    Item
    no contraindications to mri examination.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0024485 (UMLS CUI [1,3])
    MRI Absent | Ultrasonography Absent | Mammography Absent
    Item
    no prior mri, us or mammography within the 6 months prior to the study.
    boolean
    C0024485 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0041618 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0024671 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Contrast-enhanced MRI Breast
    Item
    had a screening contrast-enhanced breast mri within the past 24 months or diagnostic contrast-enhanced mri on any study breasts within the past 12 months;
    boolean
    C1707501 (UMLS CUI [1,1])
    C0006141 (UMLS CUI [1,2])
    Operation on breast | Core biopsy of breast
    Item
    had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
    boolean
    C3714726 (UMLS CUI [1])
    C0842740 (UMLS CUI [2])
    Chemotherapy | Exception Individual Cancer History | Exception Chemoprevention Tamoxifen | Exception Evista | Exception Raloxifene | Exception Arimidex | Exception Anastrozole | Exception Aromasin | Exception Exemestane | Exception Aromatase Inhibitors
    Item
    currently receiving chemotherapy [with exception to participant with personal history of cancer, and on chemoprevention with tamoxifen, evista (raloxifene), arimidex (anastrozole), aromasin (exemestane) or other aromatase inhibitor];
    boolean
    C0392920 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1512706 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0282515 (UMLS CUI [3,2])
    C0039286 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0720318 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0244404 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C0878174 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0290883 (UMLS CUI [7,2])
    C1705847 (UMLS CUI [8,1])
    C0876723 (UMLS CUI [8,2])
    C1705847 (UMLS CUI [9,1])
    C0851344 (UMLS CUI [9,2])
    C1705847 (UMLS CUI [10,1])
    C0593802 (UMLS CUI [10,2])
    Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis
    Item
    participant with severely impaired renal function with estimated glomerular filtration rate (gfr) < 30 ml/min/1.73m2 and/or on dialysis.
    boolean
    C1565489 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C3811844 (UMLS CUI [2])
    C0011946 (UMLS CUI [3])
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