The biobank is located at two sites; HUH, Bergen and SUH, Stavanger, Norway. The main aim is to collect tumor tissue, liquid biopsies (blood and urine samples), clinical follow-up data and extensive PROM-data, from a population-based cohort of consecutive operable breast cancer patients. Follow-up and surveillance of these patients will continue until 11 years after the primary treatment. We will apply to extend this monitoring until 15 years of follow-up due to the late events among the luminal breast cancer subgroups, which comprise 75% of all breast cancers.
Finally, this will result in a unique biobank resource that is fit-for-purpose to investigate new circulating tumor biomarkers related to prediction, detection and monitoring of treatment effects in operable breast cancer patients. The biobank aims to enable analysis of both primary tumor and circulating tumor cells, nucleic acids (ctDNA and microRNA) and metabolites using state-of-the-art technology. The ultimate goal is to develop novel tests that can detect systemic relapse on the earliest possible level. Thus, the patients may get an early-as-possible secondary adjuvant treatment to increase long-term survival (20-year perspective).
The participants are informed both orally and written about the general biobank and have signed a broad informed consent. Accrual of patients to the biobank and collection of material takes place at HUH and SUH and the samples are stored at the respective study site.
At the regional level, approximately 700 new breast cancer patients are diagnosed annually in western Norway. Of these, more than 500 belong to the catchment area of HUH and SUH (approx. 310 and 220 respectively). Women diagnosed with operable breast cancer (Stage I and II) at HUS and SUS are consecutively enrolled in the PBCB- project, i.e. agreed to be followed-up prospectively for 11 years. One unique population feature is that people who live in this catchment area rarely move or seek care elsewhere. Hence, a near-complete follow-up of patients is possible, which create population-based cohorts of highly committed patients. To illustrate, the drop-out rate is only 8% at SUH.
The PBCB has consent in place that allows the retrieval of a wide range of phenotypic and clinical data that is highly relevant for breast cancer research.
Relevant clinical information is retrieved directly from the hospital electronic medical records (EMRs) for each visit and is stored in a fire wall protected database. In total, 94 different variables are collected in various categories, such as diagnosis, staging, histological grade, hormone status (ER/PR), HER-2 status, surgery, chemotherapy, radiation, endocrine therapy, patient status (metastasis, medicines and co-malignancies).The patient-reported outcome measures (PROM) is self-reported data that includes information on other co-morbidities, treatment given, health problems last 30 days, smoking, co-medications, socioeconomic status, family history, information about menarche and last pregnancy, diet habits and muscle and joint pain.
The patient-reported outcome measures (PROM) is self-reported data that includes information on other co-morbidities, treatment given, health problems last 30 days, smoking, co-medications, socioeconomic status, family history, infomation about menarche and last pregnancy, diet habits and muscle and joint pain.
Moreover, the following PROM-instruments are reported annually and includes:
- EORTC-QLQ-C30, “Quality of life of cancer patients”
- EORTC-QLQ-BR23 “Breast cancer-specific quality of life questionnaire”
- Mishel uncertainty in illness scale, MUI
- Hospital Anxiety and Despression, HAD
- FACT-F: Functional Assessment of Chronic Illness Therapy-Fatigue
- FACT-ES: Functional Assessment of Cancer Therapy-Endocrine Subscale
- FACT-B: Functional Assessment of Cancer Therapy – Breast
The following rating scales are administered during the visits:
- FSS : Fatigue Severity Scale
- fVAS: Fatigue Visual Analog Scale
Subjects are also asked question of side-effects on tamoxifen and aromatase inhibitors at the visits.
In addition, approvals and consent is in place to retrieve data from a range of nationwide and mandatory registries, such as the Cancer Registry of Norway, The Medical Birth Registry, The Norwegian Cause of Death Registry (NCoDR), The Norwegian Prescription Database (NorPD), The Norwegian Patient Registry (NPR) and more.