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Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study

INTRODUCTION: Ductal carcinoma in situ (DCIS) of the breast is a non-obligate precursor of invasive breast cancer (IBC). Many DCIS patients are either undertreated or overtreated. The overarching goal of the study described here is to facilitate detection of patients with DCIS at risk of IBC develop...

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Autores principales: Rohan, Thomas E, Ginsberg, Mindy, Wang, Yihong, Couch, Fergus J, Feigelson, Heather S, Greenlee, Robert T, Honda, Stacey, Stark, Azadeh, Chitale, Dhananjay, Wang, Tao, Xue, Xiaonan, Oktay, Maja H, Sparano, Joseph A, Loudig, Olivier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549665/
https://www.ncbi.nlm.nih.gov/pubmed/34702732
http://dx.doi.org/10.1136/bmjopen-2021-053397
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author Rohan, Thomas E
Ginsberg, Mindy
Wang, Yihong
Couch, Fergus J
Feigelson, Heather S
Greenlee, Robert T
Honda, Stacey
Stark, Azadeh
Chitale, Dhananjay
Wang, Tao
Xue, Xiaonan
Oktay, Maja H
Sparano, Joseph A
Loudig, Olivier
author_facet Rohan, Thomas E
Ginsberg, Mindy
Wang, Yihong
Couch, Fergus J
Feigelson, Heather S
Greenlee, Robert T
Honda, Stacey
Stark, Azadeh
Chitale, Dhananjay
Wang, Tao
Xue, Xiaonan
Oktay, Maja H
Sparano, Joseph A
Loudig, Olivier
author_sort Rohan, Thomas E
collection PubMed
description INTRODUCTION: Ductal carcinoma in situ (DCIS) of the breast is a non-obligate precursor of invasive breast cancer (IBC). Many DCIS patients are either undertreated or overtreated. The overarching goal of the study described here is to facilitate detection of patients with DCIS at risk of IBC development. Here, we propose to use risk factor data and formalin-fixed paraffin-embedded (FFPE) DCIS tissue from a large, ethnically diverse, population-based cohort of 8175 women with a first diagnosis of DCIS and followed for subsequent IBC to: identify/validate miRNA expression changes in DCIS tissue associated with risk of subsequent IBC; evaluate ipsilateral IBC risk in association with two previously identified marker sets (triple immunopositivity for p16, COX-2, Ki67; Oncotype DX Breast DCIS score); examine the association of risk factor data with IBC risk. METHODS AND ANALYSIS: We are conducting a series of case–control studies nested within the cohort. Cases are women with DCIS who developed subsequent IBC; controls (2/case) are matched to cases on calendar year of and age at DCIS diagnosis. We project 485 cases/970 controls in the aim focused on risk factors. We estimate obtaining FFPE tissue for 320 cases/640 controls for the aim focused on miRNAs; of these, 173 cases/346 controls will be included in the aim focused on p16, COX-2 and Ki67 immunopositivity, and of the latter, 156 case–control pairs will be included in the aim focused on the Oncotype DX Breast DCIS score®. Multivariate conditional logistic regression will be used for statistical analyses. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Boards of Albert Einstein College of Medicine (IRB 2014-3611), Kaiser Permanente Colorado, Kaiser Permanente Hawaii, Henry Ford Health System, Mayo Clinic, Marshfield Clinic Research Institute and Hackensack Meridian Health, and from Lifespan Research Protection Office. The study results will be presented at meetings and published in peer-reviewed journals.
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spelling pubmed-85496652021-10-29 Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study Rohan, Thomas E Ginsberg, Mindy Wang, Yihong Couch, Fergus J Feigelson, Heather S Greenlee, Robert T Honda, Stacey Stark, Azadeh Chitale, Dhananjay Wang, Tao Xue, Xiaonan Oktay, Maja H Sparano, Joseph A Loudig, Olivier BMJ Open Epidemiology INTRODUCTION: Ductal carcinoma in situ (DCIS) of the breast is a non-obligate precursor of invasive breast cancer (IBC). Many DCIS patients are either undertreated or overtreated. The overarching goal of the study described here is to facilitate detection of patients with DCIS at risk of IBC development. Here, we propose to use risk factor data and formalin-fixed paraffin-embedded (FFPE) DCIS tissue from a large, ethnically diverse, population-based cohort of 8175 women with a first diagnosis of DCIS and followed for subsequent IBC to: identify/validate miRNA expression changes in DCIS tissue associated with risk of subsequent IBC; evaluate ipsilateral IBC risk in association with two previously identified marker sets (triple immunopositivity for p16, COX-2, Ki67; Oncotype DX Breast DCIS score); examine the association of risk factor data with IBC risk. METHODS AND ANALYSIS: We are conducting a series of case–control studies nested within the cohort. Cases are women with DCIS who developed subsequent IBC; controls (2/case) are matched to cases on calendar year of and age at DCIS diagnosis. We project 485 cases/970 controls in the aim focused on risk factors. We estimate obtaining FFPE tissue for 320 cases/640 controls for the aim focused on miRNAs; of these, 173 cases/346 controls will be included in the aim focused on p16, COX-2 and Ki67 immunopositivity, and of the latter, 156 case–control pairs will be included in the aim focused on the Oncotype DX Breast DCIS score®. Multivariate conditional logistic regression will be used for statistical analyses. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Boards of Albert Einstein College of Medicine (IRB 2014-3611), Kaiser Permanente Colorado, Kaiser Permanente Hawaii, Henry Ford Health System, Mayo Clinic, Marshfield Clinic Research Institute and Hackensack Meridian Health, and from Lifespan Research Protection Office. The study results will be presented at meetings and published in peer-reviewed journals. BMJ Publishing Group 2021-10-26 /pmc/articles/PMC8549665/ /pubmed/34702732 http://dx.doi.org/10.1136/bmjopen-2021-053397 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Epidemiology
Rohan, Thomas E
Ginsberg, Mindy
Wang, Yihong
Couch, Fergus J
Feigelson, Heather S
Greenlee, Robert T
Honda, Stacey
Stark, Azadeh
Chitale, Dhananjay
Wang, Tao
Xue, Xiaonan
Oktay, Maja H
Sparano, Joseph A
Loudig, Olivier
Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title_full Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title_fullStr Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title_full_unstemmed Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title_short Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
title_sort molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study
topic Epidemiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549665/
https://www.ncbi.nlm.nih.gov/pubmed/34702732
http://dx.doi.org/10.1136/bmjopen-2021-053397
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