ID

45835

Beschrijving

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

Trefwoorden

Versies (1)
  1. 07-08-23 07-08-23 - Simon Heim
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James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA

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7 augustus 2023

DOI

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

Engels

Eligibility Criteria

5 Formulieren  
Inclusion and exclusion criteria
Beschrijving

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.
Beschrijving

*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.

Datatype

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.
Beschrijving

*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.

Datatype

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.
Beschrijving

*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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0242802
UMLS CUI [1,3]
C5551028
UMLS CUI [1,4]
C1285573
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Similar models

Eligibility Criteria

5 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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