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ID

45835

Description

Principal Investigator: James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA MeSH: Neoplasm,Breast Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001043 *Source of patients*:The source of the patients for this genome-wide case-control study was MA.27, which was conducted as a multi-cooperative group effort under the auspices of the NCI Breast Cancer Intergroup of North America. The NCIC Clinical Trials Group (CTG) serves as the coordinating group, with participation by the NCI-sponsored North Central Cancer Treatment Group, Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group, and Cancer and Leukemia Group B (CALGB). MA.27 involved postmenopausal women with histologically confirmed and completely resected invasive breast cancer with surgical margins clear of invasive carcinoma in the following TMN categories (AJCC Version 6): pT1, pT2, pT3; pNx, pN0, pN1, pN2, pN3 (only when the sole basis is presence of 10 or more involved axillary nodes); MO. The primary tumor must have been estrogen receptor (ER) and/or progesterone receptor positive. Patients were stratified by lymph node status at diagnosis, prior adjuvant chemotherapy, and trastuzumab use and were randomized to 5 years of adjuvant therapy with anastrozole or exemestane. The trial was activated on May 26, 2003, and reached its accrual objectives on July 31, 2008, after the randomization of 6827 North American patients, with the majority (79%) providing DNA and consent for genetic testing. Non-North American patients were also entered by the International Breast Cancer Study Group but they did not contribute DNA. From 2003 to December 21, 2004, patients also underwent a second randomization to celecoxib 400 mg twice daily or placebo but, after the entry of 1,622 patients, this treatment was discontinued because of reports of increased cardiovascular risk associated with celecoxib. The final results of this study have been published, see Goss et al., 2013 (23358971). The patients in this analysis came from three cohorts: Cohort 1 consisted of 870 patients genotyped on the Illumina Human610-Quad BeadChip studied in a GWAS with the phenotype of musculoskeletal adverse event, see Ingle et al., 2010 (20876420), Cohort 2 consisted of 882 patients genotyped on the Illumina OmniExpress platform studied in a GWAS with the phenotype of fragility fractures, see Liu et al., 2014 (25148458), and the remaining 2913 patients were genotyped with the Illumina OmniExpressExome platform.

Link

dbGaP study = phs001043

Keywords

Versions (1)
  1. 8/7/23 8/7/23 - Simon Heim
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James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA

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August 7, 2023

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Creative Commons BY 4.0
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    dbGaP phs001043 GWAS of Breast Events with Adjuvant Aromatase Inhibitors

    English

    The dataset provides data about the length of the Breast Cancer Free Interval (BCFI), tumor characteristics prior to resection (e.g. estrogen/progesterone positive, lymph node status, T-/N-stage values, type of treatment used [e.g. adjuvant anastrozole or exemestane, celocoxib, herceptin, bisphonate]), bone frailty, MSK (musculoskeletal) event and basic sociodemographic data, including self-reported and genotype-based race data.

    5 forms  
    pht005315
    Description

    pht005315

    Alias
    UMLS CUI [1,1]
    C3846158
    Unique patient identifier
    Description

    SUBJECT_ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348585
    Status Indicator of having Fracture
    Description

    frailty

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018761
    UMLS CUI [1,2]
    C0016658
    Status Indicator of inclusion in 900 patient Cohort
    Description

    cohort_900

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C1512693
    UMLS CUI [1,3]
    C0599755
    Status indicator of MSK event
    Description

    RIKENcohort

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018761
    UMLS CUI [1,2]
    C4698957
    Treatment status
    Description

    mango_1_allo2_cd

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C0087111
    Stratification factor: lymph node status
    Description

    stra_nod_1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4086554
    Stratification factor: adjuvant chemotherapy
    Description

    stra_chem_1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0085533
    Stratification factor: celocoxib use
    Description

    stra_celecox_1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0538927
    UMLS CUI [1,2]
    C0042153
    Stratification factor: aspirin use
    Description

    stra_aspin_1n

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004057
    UMLS CUI [1,2]
    C0042153
    Stratification factor: herceptin use
    Description

    stra_hercep_1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0338204
    UMLS CUI [1,2]
    C0042153
    Body mass index at baseline
    Description

    BMI

    Data type

    text

    Measurement units
    • kg/m2
    Alias
    UMLS CUI [1,1]
    C1305855
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [1,3]
    C1442880
    kg/m2
    Age at randomization
    Description

    age

    Data type

    text

    Measurement units
    • Years
    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C1442880
    Years
    Self-reported race
    Description

    race

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C0034510
    ECOG (Eastern Cooperative Oncology Group) performance score
    Description

    perf_st

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1520224
    Pathologic T stage
    Description

    T_Stage__Pathologic

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C3258252
    Pathologic N stage
    Description

    N_Stage__Pathologic

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C3258251
    Estrogen receptor status
    Description

    Receptor_Status__ER

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C2919271
    Progesterone receptor status
    Description

    Receptor_Status__PgR

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C2919590
    Length of time on endocrine therapy trial (in months)
    Description

    length_of_trial_endocrine_therap

    Data type

    text

    Measurement units
    • Months
    Alias
    UMLS CUI [1,1]
    C1880501
    UMLS CUI [1,2]
    C0444921
    Months
    Bisphonate use (minimum of 30 days prior to recurrence)
    Description

    bisphophonate_use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042153
    UMLS CUI [1,2]
    C2267018
    Type of breast event - local/regional
    Description

    local_regional

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C0796563
    Type of breast event - distant
    Description

    distant

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C0027627
    Type of breast event - contralateral
    Description

    contralateral

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C1096616
    Event code for disease free survival analysis
    Description

    breastevent

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0242793
    UMLS CUI [1,2]
    C0038953
    UMLS CUI [1,3]
    C5420137
    Time from randomization to breast event for cases, and time from randomization to last follow-up for non-cases.
    Description

    breastevent_survtime

    Data type

    text

    Measurement units
    • Years
    Alias
    UMLS CUI [1,1]
    C0332168
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C1706256
    UMLS CUI [1,4]
    C0441471
    UMLS CUI [2,1]
    C0332168
    UMLS CUI [2,2]
    C0034656
    UMLS CUI [2,3]
    C5239465
    UMLS CUI [2,4]
    C0009932
    Years
    TNM stage
    Description

    tnmstage

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C3258246
    Type of breast event (cases only)
    Description

    eventtype

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0441471
    UMLS CUI [1,3]
    C1706256
    Genotypic race
    Description

    structure_race

    Data type

    string

    Alias
    UMLS CUI [1,1]
    C0034510
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    Similar models

    The dataset provides data about the length of the Breast Cancer Free Interval (BCFI), tumor characteristics prior to resection (e.g. estrogen/progesterone positive, lymph node status, T-/N-stage values, type of treatment used [e.g. adjuvant anastrozole or exemestane, celocoxib, herceptin, bisphonate]), bone frailty, MSK (musculoskeletal) event and basic sociodemographic data, including self-reported and genotype-based race data.

    5 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    pht005315
    C3846158 (UMLS CUI [1,1])
    SUBJECT_ID
    Item
    Unique patient identifier
    text
    C2348585 (UMLS CUI [1,1])
    frailty
    Item
    Status Indicator of having Fracture
    boolean
    C0018761 (UMLS CUI [1,1])
    C0016658 (UMLS CUI [1,2])
    cohort_900
    Item
    Status Indicator of inclusion in 900 patient Cohort
    boolean
    C0449438 (UMLS CUI [1,1])
    C1512693 (UMLS CUI [1,2])
    C0599755 (UMLS CUI [1,3])
    RIKENcohort
    Item
    Status indicator of MSK event
    boolean
    C0018761 (UMLS CUI [1,1])
    C4698957 (UMLS CUI [1,2])
    mango_1_allo2_cd
    Item
    Treatment status
    string
    C0087111 (UMLS CUI [1,1])
    stra_nod_1
    Item
    Stratification factor: lymph node status
    boolean
    C4086554 (UMLS CUI [1,1])
    stra_chem_1
    Item
    Stratification factor: adjuvant chemotherapy
    boolean
    C0085533 (UMLS CUI [1,1])
    stra_celecox_1
    Item
    Stratification factor: celocoxib use
    boolean
    C0538927 (UMLS CUI [1,1])
    C0042153 (UMLS CUI [1,2])
    stra_aspin_1n
    Item
    Stratification factor: aspirin use
    boolean
    C0004057 (UMLS CUI [1,1])
    C0042153 (UMLS CUI [1,2])
    stra_hercep_1
    Item
    Stratification factor: herceptin use
    boolean
    C0338204 (UMLS CUI [1,1])
    C0042153 (UMLS CUI [1,2])
    BMI
    Item
    Body mass index at baseline
    text
    C1305855 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C1442880 (UMLS CUI [1,3])
    age
    Item
    Age at randomization
    text
    C0001779 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C1442880 (UMLS CUI [1,3])
    race
    Item
    Self-reported race
    string
    C0034510 (UMLS CUI [1,1])
    perf_st
    Item
    ECOG (Eastern Cooperative Oncology Group) performance score
    text
    C1520224 (UMLS CUI [1,1])
    T_Stage__Pathologic
    Item
    Pathologic T stage
    string
    C3258252 (UMLS CUI [1,1])
    N_Stage__Pathologic
    Item
    Pathologic N stage
    string
    C3258251 (UMLS CUI [1,1])
    Receptor_Status__ER
    Item
    Estrogen receptor status
    string
    C2919271 (UMLS CUI [1,1])
    Receptor_Status__PgR
    Item
    Progesterone receptor status
    string
    C2919590 (UMLS CUI [1,1])
    length_of_trial_endocrine_therap
    Item
    Length of time on endocrine therapy trial (in months)
    text
    C1880501 (UMLS CUI [1,1])
    C0444921 (UMLS CUI [1,2])
    bisphophonate_use
    Item
    Bisphonate use (minimum of 30 days prior to recurrence)
    boolean
    C0042153 (UMLS CUI [1,1])
    C2267018 (UMLS CUI [1,2])
    local_regional
    Item
    Type of breast event - local/regional
    string
    C0796563 (UMLS CUI [1,1])
    distant
    Item
    Type of breast event - distant
    string
    C0027627 (UMLS CUI [1,1])
    contralateral
    Item
    Type of breast event - contralateral
    string
    C1096616 (UMLS CUI [1,1])
    Item
    Event code for disease free survival analysis
    text
    C0242793 (UMLS CUI [1,1])
    C0038953 (UMLS CUI [1,2])
    C5420137 (UMLS CUI [1,3])
    breastevent
    Code List
    Event code for disease free survival analysis
    CL Item
    No Event (0)
    CL Item
    Event (1)
    breastevent_survtime
    Item
    Time from randomization to breast event for cases, and time from randomization to last follow-up for non-cases.
    text
    C0332168 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C1706256 (UMLS CUI [1,3])
    C0441471 (UMLS CUI [1,4])
    C0332168 (UMLS CUI [2,1])
    C0034656 (UMLS CUI [2,2])
    C5239465 (UMLS CUI [2,3])
    C0009932 (UMLS CUI [2,4])
    tnmstage
    Item
    TNM stage
    string
    C3258246 (UMLS CUI [1,1])
    eventtype
    Item
    Type of breast event (cases only)
    text
    C0332307 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    C1706256 (UMLS CUI [1,3])
    structure_race
    Item
    Genotypic race
    string
    C0034510 (UMLS CUI [1,1])
    Back to the top of the page 

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