Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088)
Abstract Background Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor spe...
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| Language: | English |
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BMC
2020-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04568-9 |
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| author | Igor Monsellato Elisabetta Garibaldi Elisa Cassinotti Ludovica Baldari Luigi Boni Ugo Elmore Roberto Delpini Riccardo Rosati Roberto Perinotti Filippo Alongi Elisa Bertocchi Stefania Gori Giacomo Ruffo Graziano Pernazza Fabio Pulighe Carlo De Nisco Emilio Morpurgo Tania Contardo Enzo Mammano Federico Perna Benedetta Menegatti Andrea Coratti Piero Buccianti Riccardo Balestri Cristina Ceccarelli Davide Cavaliere Leonardo Solaini Giorgio Ercolani Elena Traverso Vittorio Fusco Valter Torri Sara Orecchia |
| author_facet | Igor Monsellato Elisabetta Garibaldi Elisa Cassinotti Ludovica Baldari Luigi Boni Ugo Elmore Roberto Delpini Riccardo Rosati Roberto Perinotti Filippo Alongi Elisa Bertocchi Stefania Gori Giacomo Ruffo Graziano Pernazza Fabio Pulighe Carlo De Nisco Emilio Morpurgo Tania Contardo Enzo Mammano Federico Perna Benedetta Menegatti Andrea Coratti Piero Buccianti Riccardo Balestri Cristina Ceccarelli Davide Cavaliere Leonardo Solaini Giorgio Ercolani Elena Traverso Vittorio Fusco Valter Torri Sara Orecchia |
| author_sort | Igor Monsellato |
| collection | DOAJ |
| description | Abstract Background Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading and lymph node status helped to visualize individual tumor sensitivity to chemoradiotherapy, retrospectively. As the response to neoadjuvant chemoradiotherapy is heterogeneous, however, valid biomarkers are needed to monitor tumor response. A relevant number of studies aimed to identify molecular markers retrieved from tumor tissue while the relevance of blood-based biomarkers is less stringent assessed. MicroRNAs are currently under investigation to serve as blood-based biomarkers. To date, no screening approach to identify relevant miRNAs as biomarkers in blood of patients with rectal cancer was undertaken. The aim of the study is to investigate the role of circulating miRNAs as biomarkers in those patients included in the TiMiSNAR Trial (NCT 03465982). This is a biomolecular substudy of TiMiSNAR Trial (NCT03962088). Methods All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery, and after adjuvant chemotherapy whenever indicated. Discussion TiMiSNAR-MIRNA will evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pathological complete response. Moreover, the study will evaluate the role of liquid biopsies in the monitoring of treatment, correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival, and evaluate the relation between changes in miRNA during surveillance and tumor relapse. Trial registration Clinicaltrials.gov NCT03962088 . Registered on 23 May 2019. |
| first_indexed | 2024-12-13T00:18:12Z |
| format | Article |
| id | doaj.art-0795aa4e705041fe835f6a6efbd83c87 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T00:18:12Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0795aa4e705041fe835f6a6efbd83c872022-12-22T00:05:42ZengBMCTrials1745-62152020-07-012111710.1186/s13063-020-04568-9Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088)Igor Monsellato0Elisabetta Garibaldi1Elisa Cassinotti2Ludovica Baldari3Luigi Boni4Ugo Elmore5Roberto Delpini6Riccardo Rosati7Roberto Perinotti8Filippo Alongi9Elisa Bertocchi10Stefania Gori11Giacomo Ruffo12Graziano Pernazza13Fabio Pulighe14Carlo De Nisco15Emilio Morpurgo16Tania Contardo17Enzo Mammano18Federico Perna19Benedetta Menegatti20Andrea Coratti21Piero Buccianti22Riccardo Balestri23Cristina Ceccarelli24Davide Cavaliere25Leonardo Solaini26Giorgio Ercolani27Elena Traverso28Vittorio Fusco29Valter Torri30Sara Orecchia31Department of Surgery, Azienda Ospedaliera SS. Antonio e Biagio e Cesare ArrigoDepartment of Radiation Oncology, Azienda Ospedaliera SS. Antonio e Biagio e Cesare ArrigoDepartment of Surgery, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, University of MilanDepartment of Surgery, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, University of MilanDepartment of Surgery, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, University of MilanOspedale San raffaele IRCCSOspedale San raffaele IRCCSOspedale San raffaele IRCCSOspedale degli InfermiOspedale Sacro Cuore Don CalabriaOspedale Sacro Cuore Don CalabriaOspedale Sacro Cuore Don CalabriaOspedale Sacro Cuore Don CalabriaAzienda Ospedaliera San Giovanni AddolorataOspedale San FrancescoOspedale San FrancescoOspedale Civile Pietro Cosma, Camposampiero/Ospedale Sant’AntonioOspedale Civile Pietro Cosma, CamposampieroOspedale Civile Pietro Cosma, Camposampiero/Ospedale Sant’AntonioAzienda Ospedaliero Universitaria CareggiAzienda Ospedaliero Universitaria CareggiAzienda Ospedaliero Universitaria CareggiAzienda Ospedaliero Universitaria PisanaAzienda Ospedaliero Universitaria PisanaAzienda Ospedaliero Universitaria PisanaOspedale “G.B. Morgagni L. Pierantoni”Ospedale “G.B. Morgagni L. Pierantoni”Ospedale “G.B. Morgagni L. Pierantoni”Department of Oncology, Azienda Ospedaliera SS. Antonio e Biagio e Cesare ArrigoDepartment of Oncology, Azienda Ospedaliera SS. Antonio e Biagio e Cesare ArrigoIstituto di Ricerche Farmacologiche Mario Negri IRCCSDepartment of Pathology, Azienda Ospedaliera SS. Antonio e Biagio e Cesare ArrigoAbstract Background Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading and lymph node status helped to visualize individual tumor sensitivity to chemoradiotherapy, retrospectively. As the response to neoadjuvant chemoradiotherapy is heterogeneous, however, valid biomarkers are needed to monitor tumor response. A relevant number of studies aimed to identify molecular markers retrieved from tumor tissue while the relevance of blood-based biomarkers is less stringent assessed. MicroRNAs are currently under investigation to serve as blood-based biomarkers. To date, no screening approach to identify relevant miRNAs as biomarkers in blood of patients with rectal cancer was undertaken. The aim of the study is to investigate the role of circulating miRNAs as biomarkers in those patients included in the TiMiSNAR Trial (NCT 03465982). This is a biomolecular substudy of TiMiSNAR Trial (NCT03962088). Methods All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery, and after adjuvant chemotherapy whenever indicated. Discussion TiMiSNAR-MIRNA will evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pathological complete response. Moreover, the study will evaluate the role of liquid biopsies in the monitoring of treatment, correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival, and evaluate the relation between changes in miRNA during surveillance and tumor relapse. Trial registration Clinicaltrials.gov NCT03962088 . Registered on 23 May 2019.http://link.springer.com/article/10.1186/s13063-020-04568-9Colorectal cancermiRNANeoadjuvant treatmentBiomarkersTranslational research |
| spellingShingle | Igor Monsellato Elisabetta Garibaldi Elisa Cassinotti Ludovica Baldari Luigi Boni Ugo Elmore Roberto Delpini Riccardo Rosati Roberto Perinotti Filippo Alongi Elisa Bertocchi Stefania Gori Giacomo Ruffo Graziano Pernazza Fabio Pulighe Carlo De Nisco Emilio Morpurgo Tania Contardo Enzo Mammano Federico Perna Benedetta Menegatti Andrea Coratti Piero Buccianti Riccardo Balestri Cristina Ceccarelli Davide Cavaliere Leonardo Solaini Giorgio Ercolani Elena Traverso Vittorio Fusco Valter Torri Sara Orecchia Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) Trials Colorectal cancer miRNA Neoadjuvant treatment Biomarkers Translational research |
| title | Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) |
| title_full | Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) |
| title_fullStr | Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) |
| title_full_unstemmed | Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) |
| title_short | Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088) |
| title_sort | expression levels of circulating mirnas as biomarkers during multimodal treatment of rectal cancer timisnar mirna a substudy of the timisnar trial nct03962088 |
| topic | Colorectal cancer miRNA Neoadjuvant treatment Biomarkers Translational research |
| url | http://link.springer.com/article/10.1186/s13063-020-04568-9 |
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