液体活检和患者报告的结局测量在早期乳腺癌患者综合监测中的应用：前瞻性乳腺癌生物样本库（PBCB）纵向观察研究的研究方案。

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.

机构信息

Department of Breast and Endocrine Surgery, Stavanger University Hospital, Stavanger, Norway

Department of Clinical Science, University of Bergen, Bergen, Norway.

出版信息

BMJ Open. 2022 Apr 29;12(4):e054404. doi: 10.1136/bmjopen-2021-054404.

DOI:10.1136/bmjopen-2021-054404

PMID:35487718

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9058781/

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.

摘要

简介

乳腺癌仍然是全世界女性中最常见的恶性肿瘤。前瞻性乳腺癌生物库（PBCB）从 2011 年至 2030 年，在挪威西部的两家大学医院，每 6 或 12 个月收集一次患有乳腺癌的患者的血液和尿液，为期 11 年。该项目旨在确定新的生物标志物，以便在分子水平上检测系统性复发。由于血液代表原发性肿瘤、微环境和远处转移之间的生物学界面，因此液体活检代表了监测患者癌症生物学的理想介质，可用于识别复发风险高的患者，并早期检测系统性复发。纳入患者报告的结果测量（PROMs）可以提供大量可能性，将 PROM 数据与生物学信息进行比较，从而研究乳腺癌患者的疲劳和生活质量。

方法和分析

共有 1455 名早期乳腺癌患者参加了 PBCB 研究，该研究采用单臂前瞻性观察设计。参与者同意每 6 或 12 个月采集一次液体活检（即外周血和尿液样本），为期 11 年。这些液体活检是检测循环肿瘤细胞、循环肿瘤 DNA（ctDNA）、外泌体 micro-RNA（miRNA）、肿瘤教育血小板中的 miRNA 和代谢组学谱的基础。此外，参与者每年会回复 10 份 PROM 调查问卷。此外，还将由 200 名年龄在 25-70 岁之间无癌症的女性组成对照组，提供相同的数据。

伦理和传播

一般研究生物库 PBCB 于 2007 年获得卫生和保健服务部批准，于 2010 年获得地区伦理委员会（REK）批准（2010/1957）。PROM（2011/2161）和生物标志物研究 PerMoBreCan（2015/2010）分别于 2011 年和 2015 年获得 REK 批准。结果将发表在国际同行评审期刊上。请求后将提供匿名数据。