Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol
Introduction Standard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potent...
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e054256.full |
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| author | Gabriele Zoppoli Alberto Ballestrero Valerio Gaetano Vellone Piero Fregatti Francesco Ravera Gabriella Cirmena Martina Dameri Maurizio Gallo Daniele Friedman Massimo Calabrese Alberto Tagliafico Lorenzo Ferrando |
| author_facet | Gabriele Zoppoli Alberto Ballestrero Valerio Gaetano Vellone Piero Fregatti Francesco Ravera Gabriella Cirmena Martina Dameri Maurizio Gallo Daniele Friedman Massimo Calabrese Alberto Tagliafico Lorenzo Ferrando |
| author_sort | Gabriele Zoppoli |
| collection | DOAJ |
| description | Introduction Standard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potential in BC management.Methods and analysis This is a prospective translational study investigating the accuracy of the combined assessment of multiple circulating analytes together with radiomic variables for early BC diagnosis. Up to 750 patients will be recruited at their presentation at the Diagnostic Senology Unit of Ospedale Policlinico San Martino (Genoa, IT) for the execution of a diagnostic biopsy after the detection of a suspect breast lesion (t0). Each recruited patient will be asked to donate peripheral blood and urine before undergoing breast biopsy. Blood and urine samples will also be collected from a cohort of 100 patients with negative mammography. For cases with histological diagnosis of invasive BC, a second sample of blood and urine will be collected after breast surgery. Circulating tumour DNA, cell-free methylated DNA and circulating proteins will be assessed in samples collected at t0 from patients with stage I–IIA BC at surgery together with those collected from patients with histologically confirmed benign lesions of similar size and from healthy controls with negative mammography. These analyses will be combined with radiomic variables extracted with freeware algorithms applied to cases and matched controls for which digital mammography is available. The overall goal of the present study is to develop a horizontal data integration classifier for the early diagnosis of BC.Ethics and dissemination This research protocol has been approved by Regione Liguria Ethics Committee (reference number: 2019/75, study ID: 4452). Patients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals.Trial registration number NCT04781062. |
| format | Article |
| id | doaj-art-0276bc9ca93e4f868f69cde3aa01d125 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0276bc9ca93e4f868f69cde3aa01d1252025-08-20T01:59:13ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-054256Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocolGabriele Zoppoli0Alberto Ballestrero1Valerio Gaetano Vellone2Piero Fregatti3Francesco Ravera4Gabriella Cirmena5Martina Dameri6Maurizio Gallo7Daniele Friedman8Massimo Calabrese9Alberto Tagliafico10Lorenzo Ferrando11Division of Internal Medicine and Oncology, IRCCS Ospedale Policlinico San Martino, Genova, ItalyDepartment of Internal Medicine, University of Genoa, Genova, Italy3 Anatomic Pathology University Unit, IRCCS Ospedale Policlinico San Martino, Genova, Liguria, ItalyOspedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, ItalyDepartment of Internal Medicine, Università degli Studi di Genova, Genova, ItalyDepartment of Internal Medicine, Università degli Studi di Genova, Genova, ItalyOspedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, ItalyDepartment of Internal Medicine, Università degli Studi di Genova, Genova, ItalyOspedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, ItalyOspedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, ItalyHealth Sciences, University of Genoa, Genova, ItalyOspedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, ItalyIntroduction Standard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potential in BC management.Methods and analysis This is a prospective translational study investigating the accuracy of the combined assessment of multiple circulating analytes together with radiomic variables for early BC diagnosis. Up to 750 patients will be recruited at their presentation at the Diagnostic Senology Unit of Ospedale Policlinico San Martino (Genoa, IT) for the execution of a diagnostic biopsy after the detection of a suspect breast lesion (t0). Each recruited patient will be asked to donate peripheral blood and urine before undergoing breast biopsy. Blood and urine samples will also be collected from a cohort of 100 patients with negative mammography. For cases with histological diagnosis of invasive BC, a second sample of blood and urine will be collected after breast surgery. Circulating tumour DNA, cell-free methylated DNA and circulating proteins will be assessed in samples collected at t0 from patients with stage I–IIA BC at surgery together with those collected from patients with histologically confirmed benign lesions of similar size and from healthy controls with negative mammography. These analyses will be combined with radiomic variables extracted with freeware algorithms applied to cases and matched controls for which digital mammography is available. The overall goal of the present study is to develop a horizontal data integration classifier for the early diagnosis of BC.Ethics and dissemination This research protocol has been approved by Regione Liguria Ethics Committee (reference number: 2019/75, study ID: 4452). Patients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals.Trial registration number NCT04781062.https://bmjopen.bmj.com/content/11/12/e054256.full |
| spellingShingle | Gabriele Zoppoli Alberto Ballestrero Valerio Gaetano Vellone Piero Fregatti Francesco Ravera Gabriella Cirmena Martina Dameri Maurizio Gallo Daniele Friedman Massimo Calabrese Alberto Tagliafico Lorenzo Ferrando Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol BMJ Open |
| title | Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol |
| title_full | Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol |
| title_fullStr | Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol |
| title_full_unstemmed | Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol |
| title_short | Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol |
| title_sort | development of a horizontal data integration classifier for non invasive early diagnosis of breast cancer the renovate study protocol |
| url | https://bmjopen.bmj.com/content/11/12/e054256.full |
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