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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.

Lien

dbGaP study = phs001043

Mots-clés

Versions (1)
  1. 07/08/2023 07/08/2023 - Simon Heim
Détendeur de droits

James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA

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7 août 2023

DOI

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Licence

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

    Anglais

    Eligibility Criteria

    5 Formulaires  
    Inclusion and exclusion criteria
    Description

    Inclusion and exclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    *Inclusion criteria for parent clinical trial*: The trial from which the patients in this case-control study were identified was MA.27. Inclusion criteria included 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 ER and/or progesterone receptor positive.
    Description

    *Inclusion criteria for parent clinical trial*: The trial from which the patients in this case-control study were identified was MA.27. Inclusion criteria included 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 ER and/or progesterone receptor positive.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0007328
    UMLS CUI [1,4]
    C1269815
    UMLS CUI [2,1]
    C0242801
    UMLS CUI [2,2]
    C1512693
    UMLS CUI [2,3]
    C0232970
    UMLS CUI [2,4]
    C0043210
    UMLS CUI [2,5]
    C0853879
    UMLS CUI [2,6]
    C0679557
    UMLS CUI [2,7]
    C0475288
    UMLS CUI [2,8]
    C0332391
    UMLS CUI [2,9]
    C0332392
    UMLS CUI [2,10]
    C0332393
    UMLS CUI [2,11]
    C0332401
    UMLS CUI [2,12]
    C0332397
    UMLS CUI [2,13]
    C0332398
    UMLS CUI [2,14]
    C0332399
    UMLS CUI [2,15]
    C0279754
    UMLS CUI [2,16]
    C0279759
    *Case Definition Breast Cancer Events*: The primary outcome evaluated was Breast Cancer Free Interval (BCFI), defined as the time from randomization to the first local-regional breast cancer recurrence (including ipsilateral ductal carcinoma in situ [DCIS]), distant breast cancer recurrence, contralateral breast cancer (invasive or DCIS) or death with or from breast cancer without prior recurrence date. Follow-up was censored at non-breast cancer death, or longest follow-up without recurrence. *Cases* were defined as those patients who experienced a BCFI event and *controls* were those patients who did not experience such an event.
    Description

    *Case Definition Breast Cancer Events*: The primary outcome evaluated was Breast Cancer Free Interval (BCFI), defined as the time from randomization to the first local-regional breast cancer recurrence (including ipsilateral ductal carcinoma in situ [DCIS]), distant breast cancer recurrence, contralateral breast cancer (invasive or DCIS) or death with or from breast cancer without prior recurrence date. Follow-up was censored at non-breast cancer death, or longest follow-up without recurrence. *Cases* were defined as those patients who experienced a BCFI event and *controls* were those patients who did not experience such an event.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C1706256
    UMLS CUI [1,3]
    C3274433
    UMLS CUI [1,4]
    C0677874
    UMLS CUI [1,5]
    C0872291
    UMLS CUI [1,6]
    C1704788
    UMLS CUI [1,7]
    C0034656
    UMLS CUI [1,8]
    C0278493
    UMLS CUI [1,9]
    C0007124
    UMLS CUI [1,10]
    C0443203
    UMLS CUI [1,11]
    C1306577
    UMLS CUI [2,1]
    C1522577
    UMLS CUI [2,2]
    C3889990
    UMLS CUI [2,3]
    C4722463
    UMLS CUI [2,4]
    C1518422
    UMLS CUI [2,5]
    C0678222
    UMLS CUI [2,6]
    C1513491
    UMLS CUI [2,7]
    C1522577
    UMLS CUI [2,8]
    C1532381
    *Selection of Controls*: All patients who were treated on protocol and who had genotyping performed were utilized as controls. These patients came from 3 cohorts: Cohort 1: patients genotyped.
    Description

    *Selection of Controls*: All patients who were treated on protocol and who had genotyping performed were utilized as controls. These patients came from 3 cohorts: Cohort 1: patients genotyped.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009932
    UMLS CUI [1,2]
    C0242802
    UMLS CUI [1,3]
    C5551028
    UMLS CUI [1,4]
    C1285573
    Retour au début de la page

    Similar models

    Eligibility Criteria

    5 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Inclusion and exclusion criteria
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    *Inclusion criteria for parent clinical trial*: The trial from which the patients in this case-control study were identified was MA.27. Inclusion criteria included 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 ER and/or progesterone receptor positive.
    Item
    *Inclusion criteria for parent clinical trial*: The trial from which the patients in this case-control study were identified was MA.27. Inclusion criteria included 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 ER and/or progesterone receptor positive.
    boolean
    C1512693 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0007328 (UMLS CUI [1,3])
    C1269815 (UMLS CUI [1,4])
    C0242801 (UMLS CUI [2,1])
    C1512693 (UMLS CUI [2,2])
    C0232970 (UMLS CUI [2,3])
    C0043210 (UMLS CUI [2,4])
    C0853879 (UMLS CUI [2,5])
    C0679557 (UMLS CUI [2,6])
    C0475288 (UMLS CUI [2,7])
    C0332391 (UMLS CUI [2,8])
    C0332392 (UMLS CUI [2,9])
    C0332393 (UMLS CUI [2,10])
    C0332401 (UMLS CUI [2,11])
    C0332397 (UMLS CUI [2,12])
    C0332398 (UMLS CUI [2,13])
    C0332399 (UMLS CUI [2,14])
    C0279754 (UMLS CUI [2,15])
    C0279759 (UMLS CUI [2,16])
    *Case Definition Breast Cancer Events*: The primary outcome evaluated was Breast Cancer Free Interval (BCFI), defined as the time from randomization to the first local-regional breast cancer recurrence (including ipsilateral ductal carcinoma in situ [DCIS]), distant breast cancer recurrence, contralateral breast cancer (invasive or DCIS) or death with or from breast cancer without prior recurrence date. Follow-up was censored at non-breast cancer death, or longest follow-up without recurrence. *Cases* were defined as those patients who experienced a BCFI event and *controls* were those patients who did not experience such an event.
    Item
    *Case Definition Breast Cancer Events*: The primary outcome evaluated was Breast Cancer Free Interval (BCFI), defined as the time from randomization to the first local-regional breast cancer recurrence (including ipsilateral ductal carcinoma in situ [DCIS]), distant breast cancer recurrence, contralateral breast cancer (invasive or DCIS) or death with or from breast cancer without prior recurrence date. Follow-up was censored at non-breast cancer death, or longest follow-up without recurrence. *Cases* were defined as those patients who experienced a BCFI event and *controls* were those patients who did not experience such an event.
    boolean
    C0678222 (UMLS CUI [1,1])
    C1706256 (UMLS CUI [1,2])
    C3274433 (UMLS CUI [1,3])
    C0677874 (UMLS CUI [1,4])
    C0872291 (UMLS CUI [1,5])
    C1704788 (UMLS CUI [1,6])
    C0034656 (UMLS CUI [1,7])
    C0278493 (UMLS CUI [1,8])
    C0007124 (UMLS CUI [1,9])
    C0443203 (UMLS CUI [1,10])
    C1306577 (UMLS CUI [1,11])
    C1522577 (UMLS CUI [2,1])
    C3889990 (UMLS CUI [2,2])
    C4722463 (UMLS CUI [2,3])
    C1518422 (UMLS CUI [2,4])
    C0678222 (UMLS CUI [2,5])
    C1513491 (UMLS CUI [2,6])
    C1522577 (UMLS CUI [2,7])
    C1532381 (UMLS CUI [2,8])
    *Selection of Controls*: All patients who were treated on protocol and who had genotyping performed were utilized as controls. These patients came from 3 cohorts: Cohort 1: patients genotyped.
    Item
    *Selection of Controls*: All patients who were treated on protocol and who had genotyping performed were utilized as controls. These patients came from 3 cohorts: Cohort 1: patients genotyped.
    boolean
    C0009932 (UMLS CUI [1,1])
    C0242802 (UMLS CUI [1,2])
    C5551028 (UMLS CUI [1,3])
    C1285573 (UMLS CUI [1,4])
    Retour au début de la page 

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