Liquid biopsies and patient-reported outcome measures for integrative monitoring of patients with early-stage breast cancer: a study protocol for the longitudinal observational Prospective Breast Cancer Biobanking (PBCB) study

• Authors: Håvard Søiland, Stavanger University Hospital; Emiel AM Janssen, Stavanger University Hospital; Thomas Helland, University of Bergen; Finn M Eliassen, Stavanger University Hospital; Magnus Hagland, University of Bergen; Oddmund Nordgard, Stavanger University Hospital; Siri Lunde, Stavanger University Hospital; Tone Hoel Lende, Stavanger University Hospital; Jørn Vegard Sagen, University of Bergen; Kjersti Tjensvoll, Stavanger University Hospital; Bjørnar Gilje, Stavanger University Hospital; Kristin Jonsdottir, Stavanger University Hospital; Einar Gudlaugsson, Stavanger University Hospital; Kirsten Lode, Stavanger University Hospital; Kari Britt Hagen, Haukeland University Hospital; Birgitta Haga Gripsrud, University of Stavanger; Ragna Lind, Haukeland University Hospital; Anette Heie, Haukeland University Hospital; Turid Aas, Haukeland University Hospital; Marie Austdal, Stavanger University Hospital; Nina G Egeland, Stavanger University Hospital; Tomm Bernklev, Central Hospital in Vestfold; Timothy Lash, Emory University; Linn Skartveit, Haukeland University Hospital; Ann Cathrine Kroksveen, Haukeland University Hospital; Satu Oltedal, Stavanger University Hospital; Jan Terje Kvaloy, Stavanger University Hospital; Ernst A Lien, University of Bergen; Linda Sleire, Haukeland University Hospital; Gunnar Mellgren, University of Bergen
• Journal Title: BMJ OPEN
• Volume: Volume 12, Number 4
• Publisher: BMJ PUBLISHING GROUP | 2022-04-01, Pages e054404-e054404
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1136/bmjopen-2021-054404
• Subjects: Health Sciences, Pharmacology; Health Sciences, Pathology; Health Sciences, Oncology; Health Sciences, Epidemiology
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, General & Internal; General & Internal Medicine; Cell biology; Pathology; MOLECULAR BIOLOGY; Breast tumours; Breast surgery; CIRCULATING TUMOR-CELLS; QUALITY-OF-LIFE; HEALTH COMPLAINTS; FUNCTIONAL ASSESSMENT; POOLED ANALYSIS; EORTC QLQ-C30; FATIGUE; VALIDATION; SCALE; HETEROGENEITY

Abstract

Introduction Breast cancer is still the most common malignancy among women worldwide. The Prospective Breast Cancer Biobank (PBCB) collects blood and urine from patients with breast cancer every 6 or 12 months for 11 years from 2011 to 2030 at two university hospitals in Western Norway. The project aims to identify new biomarkers that enable detection of systemic recurrences at the molecular level. As blood represents the biological interface between the primary tumour, the microenvironment and distant metastases, liquid biopsies represent the ideal medium to monitor the patient € s cancer biology for identification of patients at high risk of relapse and for early detection systemic relapse. Including patient-reported outcome measures (PROMs) allows for a vast number of possibilities to compare PROM data with biological information, enabling the study of fatigue and Quality of Life in patients with breast cancer. Methods and analysis A total of 1455 patients with early-stage breast cancer are enrolled in the PBCB study, which has a one-armed prospective observational design. Participants consent to contribute liquid biopsies (i.e., peripheral blood and urine samples) every 6 or 12 months for 11 years. The liquid biopsies are the basis for detection of circulating tumour cells, circulating tumour DNA (ctDNA), exosomal micro-RNA (miRNA), miRNA in Tumour Educated Platelet and metabolomic profiles. In addition, participants respond to 10 PROM questionnaires collected annually. Moreover, a control group comprising 200 women without cancer aged 25-70 years will provide the same data. Ethics and dissemination The general research biobank PBCB was approved by the Ministry of Health and Care Services in 2007, by the Regional Ethics Committee (REK) in 2010 (#2010/1957). The PROM (#2011/2161) and the biomarker study PerMoBreCan (#2015/2010) were approved by REK in 2011 and 2015 respectively. Results will be published in international peer reviewed journals. Deidentified data will be accessible on request. Trial registration number NCT04488614.