PBCB Prospective Breast Cancer Biobanking Personal monitoring of breast cancer Medicine Biomarkers Patient journey Fatigue Work-life participation Established by Ernst Lien (Bergen) Gunnar Mellgren (Bergen), Håvard Søiland (Stavanger) --- Presented by Marie Austdal, PhD Research Coordinator
2 Design Longitudinal, prospective cohort study Newly diagnosed, operable breast cancer patients in Western Norway Total goal: 1200 patients Founded in 2010 (Bergen) 2012 (Stavanger)
3 Operable breast cancer patients 11 years follow up Biobank description Diagnosis: blood draw, tissue, questionnaire (Bi-)Yearly study visits: blood draw, questionnaire Endocrine therapy switch or reduction: extra blood draws Recurrence: blood draws, metastasis tissue Urine Blood components Serum, plasma, whole blood (EDTA) PAXgene, CPT Buffy coat, platelets Circulating tumor cells Tissue Fresh frozen (FF) tumor (n~150) Paraffin-embedded tumor FF paracrine adipose tissue (n=32) Metastasis tissue if available In total 32 aliquotes total per visit stored at -80 o C
Clinical and phenotypic data Diagnoses, stages and grades Pathology Hormone status Proliferation Treatment Chemotherapy Endocrine therapy Radiation Current follow up status Active patients 312 SUS 780 HUS Relapse (SUS) 3% (SUS) 9 patients Drop-out rate 8% SUS 19% HUS Mainly T 1,2 N 0 M 0 (Stage I-II) at inclusion pt2 Tumor size in situ pt1 Diagnosis ILC DCIS IDC Nodal status pn2 pn1 pn0 DCIS, ductal carcinoma in situ; IDC, invasive ductal carcinoma; ILC, invasive lobular carcinoma 4
4 Clinical and phenotypic data Yearly questionnaires At home Self reported health status Quality of life (EORTC) Uncertainty in illness (MUIS) Hospital anxiety and depression (HAD) Dietary changes Functional assessment of cancer therapy (FACT, FACIT) At visit Fatigue (FSS, VAS) Endocrine therapy side effects Medical therapy adherence (MMAS)
Clinical and phenotypic data Databank/meta-data LabVantage sample tracking (2018 -> ) Boomerang temperature monitoring Clinical, phenotypic and questionaire data in updated Access-database Image: http://www.sysmex.co.nz 4
Clinical and phenotypic data External resources in consent General registries National person-, medical birth-, and welfare registries Specific registries The Cancer-, death-, and patient registries, the national prescription database + others Electronic medical records Consent for patient recontact Image: http://www.sysmex.co.nz 4
5 Research focus The Hormone Laboratory research group (HUS) Gunnar Mellgren Obesity, diabetes, breast cancer and stem cells. Biomarkers of disease development and responsiveness to therapy, tamoxifenn metabolism Forskningsgruppen for Brystkreft (SUS) Håvard Søiland Breast cancer biology, treatment and monitoring during follow-up Circulating tumor cells + DNA, biomarkers in primary tumor, microrna, metabolomics Areas of special interest for industry: Blood-based biomarkers Relapse detection Therapy response Medical doctors, nurses, scientists and technicians with background in medicine, endocrinology, biochemistry, molecular biology, and nutrition.
5 Research focus International collaborators: Deirdre Cronin-Fenton «Case-control biobank» Ritu Aneja Padmashree Rida «Biomarkers for therapy response» Mylin Torres Timothy Lash «Fatigue in breast cancer survivors»
6 C A S E S T U DY: TA M OX I F E N M E TA B O L I S M Tamoxifen CYP2D6 Active metabolites LC-MS/MS for metabolite measurement (Hormone Laboratory, HUS) Serum concentrations of active tamoxifen metabolites predict survival (Helland, 2017) Prospective observation study of 200 patients in PBCB: Metabolism, side effects, adherence Thomas Helland PhD Candidate Hormone Laboratory Haukeland University Hospital
7 How to collaborate? Project outline and material needs to PBCB steering committee If approved: Detailed protocol & material REK approval MTA, co-author agreement Final approval by steering committee More information at http://brystkreftforskning.no/ Contact Gunnar Mellgren gunnar.mellgren@helsebergen.no Håvard Søiland havard.soiland@sus.no