Abstract:
:Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Gallego CJ,Bennette CS,Heagerty P,Comstock B,Horike-Pyne M,Hisama F,Amendola LM,Bennett RL,Dorschner MO,Tarczy-Hornoch P,Grady WM,Fullerton SM,Trinidad SB,Regier DA,Nickerson DA,Burke W,Patrick DL,Jarvik GP,Veenstra Ddoi
10.1016/j.cct.2014.06.016subject
Has Abstractpub_date
2014-09-01 00:00:00pages
1-8issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(14)00098-6journal_volume
39pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Suboptimal diet and inactive lifestyle are among the most prevalent preventable causes of premature death. Interventions that target multiple behaviors are potentially efficient; however the optimal way to initiate and maintain multiple health behavior changes is unknown. OBJECTIVE:The Make Better Choices 2...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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更新日期:2015-03-01 00:00:00
abstract::This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n = 17) and trial-naïve (n = 99) IDUs recruited from community needle and syringe progra...
journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.10.010
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Contemporary clinical trials
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pub_type: 杂志文章
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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更新日期:2016-07-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.07.001
更新日期:2015-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.11.013
更新日期:2006-04-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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更新日期:2017-06-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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更新日期:2010-01-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.06.014
更新日期:2016-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 更正并重新发布的文章,已发布勘误
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更新日期:2020-10-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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更新日期:2007-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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更新日期:2018-02-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2017-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2006.08.004
更新日期:2007-05-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2019-04-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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更新日期:2020-11-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2005.08.002
更新日期:2006-02-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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更新日期:2015-01-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
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