0 Ratings
ID

26094

Description

Development of Vitamin D as a Therapy for Breast Cancer - Phase II; ODM derived from: https://clinicaltrials.gov/show/NCT00656019

Link

https://clinicaltrials.gov/show/NCT00656019

Keywords

Versions (2)
  1. 10/9/17 10/9/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

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October 9, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT00656019

    English

    Eligibility Breast Cancer NCT00656019

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
    Description

    Gender | Core needle biopsy | Abnormality of the breast Suspicious Breast Carcinoma | Breast Carcinoma Core needle biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C1318309
    UMLS CUI [3,1]
    C4025829
    UMLS CUI [3,2]
    C0750493
    UMLS CUI [3,3]
    C0678222
    UMLS CUI [4,1]
    C0678222
    UMLS CUI [4,2]
    C1318309
    no prior therapy for breast cancer.
    Description

    Prior Therapy Absent Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0678222
    age 18 years or older.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ability to understand and the willingness to sign a written informed consent document.
    Description

    Comprehension Informed Consent | Informed Consent Willing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0600109
    signed informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of parathyroid disease, hypercalcemia, or kidney stones.
    Description

    Parathyroid Diseases | Hypercalcemia | Kidney Calculi

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030517
    UMLS CUI [2]
    C0020437
    UMLS CUI [3]
    C0022650
    supplemental vitamin d other than from a standard multiple vitamin or from standard formulations of calcium and vitamin d (e.g. calcium citrate with vitamin d) within the prior 6 months.
    Description

    Vitamin D supplement | Exception Standard Multivitamin preparation | Exception Standard Calcium + vitamin D | Exception Calcium Citrate / Vitamin D

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3541352
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1442989
    UMLS CUI [2,3]
    C0301532
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1442989
    UMLS CUI [3,3]
    C0719107
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0719098
    history of renal failure requiring dialysis or kidney transplantation.
    Description

    Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035078
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0011946
    UMLS CUI [2,1]
    C0035078
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0022671
    women who are known to be pregnant or who are nursing. (as vitamin d does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    supplemental calcium greater than 600 mg calcium per day during study.
    Description

    Calcium supplement U/day

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3661604
    UMLS CUI [1,2]
    C0456683
    patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
    Description

    First line treatment Breast Carcinoma | Breast-Conserving Surgery Absent | Mastectomy Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1708063
    UMLS CUI [1,2]
    C0678222
    UMLS CUI [2,1]
    C0917927
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0024881
    UMLS CUI [3,2]
    C0332197
    patients with locally advanced breast cancer
    Description

    Locally advanced breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3495949
    patients planned for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy.
    Description

    Chemotherapy Neoadjuvant Planned | Hormone Therapy Planned | Systemic therapy Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0600558
    UMLS CUI [1,3]
    C1301732
    UMLS CUI [2,1]
    C0279025
    UMLS CUI [2,2]
    C1301732
    UMLS CUI [3,1]
    C1515119
    UMLS CUI [3,2]
    C1301732
    patients planned for preoperative radiation therapy.
    Description

    Therapeutic radiology procedure Preoperative Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0445204
    UMLS CUI [1,3]
    C1301732
    patients with planned surgical therapy of their breast cancer that would not allow for at least 10 days of vitamin d intervention.
    Description

    Operative Surgical Procedure Planned Breast Carcinoma | Vitamin D Intervention Illicit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [1,3]
    C0678222
    UMLS CUI [2,1]
    C0042866
    UMLS CUI [2,2]
    C0184661
    UMLS CUI [2,3]
    C0332266
    any condition potentially interfering with subjects ability to comply with taking study medication.
    Description

    Condition Interferes with Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0013230
    any medical condition that would potentially interfere with vitamin d absorption, such as celiac sprue, ulcerative colitis.
    Description

    Medical condition Interferes with Vitamin D Absorption | Celiac Disease | Ulcerative Colitis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0042866
    UMLS CUI [1,4]
    C0237442
    UMLS CUI [2]
    C0007570
    UMLS CUI [3]
    C0009324
    current participation in another research study that would increase risk to subject, in the opinion of the investigators
    Description

    Risk Increased by Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035647
    UMLS CUI [1,2]
    C0205217
    UMLS CUI [1,3]
    C2348568
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    Similar models

    Eligibility Breast Cancer NCT00656019

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Core needle biopsy | Abnormality of the breast Suspicious Breast Carcinoma | Breast Carcinoma Core needle biopsy
    Item
    women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
    boolean
    C0079399 (UMLS CUI [1])
    C1318309 (UMLS CUI [2])
    C4025829 (UMLS CUI [3,1])
    C0750493 (UMLS CUI [3,2])
    C0678222 (UMLS CUI [3,3])
    C0678222 (UMLS CUI [4,1])
    C1318309 (UMLS CUI [4,2])
    Prior Therapy Absent Breast Carcinoma
    Item
    no prior therapy for breast cancer.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [1,3])
    Age
    Item
    age 18 years or older.
    boolean
    C0001779 (UMLS CUI [1])
    Comprehension Informed Consent | Informed Consent Willing
    Item
    ability to understand and the willingness to sign a written informed consent document.
    boolean
    C0162340 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0600109 (UMLS CUI [2,2])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Parathyroid Diseases | Hypercalcemia | Kidney Calculi
    Item
    history of parathyroid disease, hypercalcemia, or kidney stones.
    boolean
    C0030517 (UMLS CUI [1])
    C0020437 (UMLS CUI [2])
    C0022650 (UMLS CUI [3])
    Vitamin D supplement | Exception Standard Multivitamin preparation | Exception Standard Calcium + vitamin D | Exception Calcium Citrate / Vitamin D
    Item
    supplemental vitamin d other than from a standard multiple vitamin or from standard formulations of calcium and vitamin d (e.g. calcium citrate with vitamin d) within the prior 6 months.
    boolean
    C3541352 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1442989 (UMLS CUI [2,2])
    C0301532 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C1442989 (UMLS CUI [3,2])
    C0719107 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0719098 (UMLS CUI [4,2])
    Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation
    Item
    history of renal failure requiring dialysis or kidney transplantation.
    boolean
    C0035078 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0011946 (UMLS CUI [1,3])
    C0035078 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0022671 (UMLS CUI [2,3])
    Pregnancy | Breast Feeding
    Item
    women who are known to be pregnant or who are nursing. (as vitamin d does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Calcium supplement U/day
    Item
    supplemental calcium greater than 600 mg calcium per day during study.
    boolean
    C3661604 (UMLS CUI [1,1])
    C0456683 (UMLS CUI [1,2])
    First line treatment Breast Carcinoma | Breast-Conserving Surgery Absent | Mastectomy Absent
    Item
    patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
    boolean
    C1708063 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    C0917927 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0024881 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Locally advanced breast cancer
    Item
    patients with locally advanced breast cancer
    boolean
    C3495949 (UMLS CUI [1])
    Chemotherapy Neoadjuvant Planned | Hormone Therapy Planned | Systemic therapy Planned
    Item
    patients planned for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy.
    boolean
    C0392920 (UMLS CUI [1,1])
    C0600558 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    C0279025 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    C1515119 (UMLS CUI [3,1])
    C1301732 (UMLS CUI [3,2])
    Therapeutic radiology procedure Preoperative Planned
    Item
    patients planned for preoperative radiation therapy.
    boolean
    C1522449 (UMLS CUI [1,1])
    C0445204 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Operative Surgical Procedure Planned Breast Carcinoma | Vitamin D Intervention Illicit
    Item
    patients with planned surgical therapy of their breast cancer that would not allow for at least 10 days of vitamin d intervention.
    boolean
    C0543467 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [1,3])
    C0042866 (UMLS CUI [2,1])
    C0184661 (UMLS CUI [2,2])
    C0332266 (UMLS CUI [2,3])
    Condition Interferes with Investigational New Drugs
    Item
    any condition potentially interfering with subjects ability to comply with taking study medication.
    boolean
    C0348080 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0013230 (UMLS CUI [1,3])
    Medical condition Interferes with Vitamin D Absorption | Celiac Disease | Ulcerative Colitis
    Item
    any medical condition that would potentially interfere with vitamin d absorption, such as celiac sprue, ulcerative colitis.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0042866 (UMLS CUI [1,3])
    C0237442 (UMLS CUI [1,4])
    C0007570 (UMLS CUI [2])
    C0009324 (UMLS CUI [3])
    Risk Increased by Study Subject Participation Status
    Item
    current participation in another research study that would increase risk to subject, in the opinion of the investigators
    boolean
    C0035647 (UMLS CUI [1,1])
    C0205217 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
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