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The BMC Medicine breast cancer collection: an illustration of contemporary research and clinical care.

ABSTRACT: The field of breast cancer had witnessed clear improvements in survival and less morbidity over the last few decades owing to earlier detection as a result of public awareness and screening, as well as treatments involving the disciplines of surgical, radiation and medical oncology along with advances in imaging and pathological diagnostics. However, in the last 5-10 years, newer assays and biological therapies have begun to cross new boundaries with higher rates of cure seen in more aggressive cancers. Even though metastatic breast cancer remains incurable, some, but not all, subsets of patients with breast cancer are living longer and more productive lives. Many challenges still remain, and the development of team science coupled with collaborative clinical research and care is expected to accelerate advances along this trajectory.

SUBMITTER: Tripathy D

PROVIDER: S-EPMC4580146 | biostudies-other | 2015 Sep

REPOSITORIES: biostudies-other

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The BMC Medicine breast cancer collection: an illustration of contemporary research and clinical care.

Tripathy Debu D

BMC medicine 20150923

The field of breast cancer had witnessed clear improvements in survival and less morbidity over the last few decades owing to earlier detection as a result of public awareness and screening, as well as treatments involving the disciplines of surgical, radiation and medical oncology along with advances in imaging and pathological diagnostics. However, in the last 5-10 years, newer assays and biological therapies have begun to cross new boundaries with higher rates of cure seen in more aggressive ...[more]

PMID: 26394747

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Project description:Systematic collection of fresh tissues for research at the time of diagnostic image-guided breast biopsy has the potential to fuel a wide variety of innovative studies. Here we report the initial experience, including safety, feasibility and laboratory proof-of-principle, with the collection and analysis of research specimens obtained via breast core needle biopsy immediately following routine clinical biopsy at a single institution over a 14-month period. Study eligibility criteria consisted of patients age 18 or older who were undergoing a clinical breast needle biopsy. Patients providing informed consent underwent one or two additional core biopsies following collection of all necessary clinical specimens. In total, 395 patients were approached and 270 consented to the research study, yielding a 68.4% consent rate. Among consenting patients, 238 lesions were biopsied for research, resulting in 446 research specimens collected. No immediate complications were observed. During the same period, zero complications were reported among the non-research procedures (1622 breast biopsy procedures). Representative research core specimens showed high diagnostic concordance with clinical core biopsies. Flow cytometry demonstrated consistent recovery of hundreds to thousands of viable cells per research core. Among a group of HER2+ tumor research specimens, HER2 assessment by flow cytometry correlated highly with immunohistochemistry (IHC) staining, and in addition revealed extensive inter- and intra-tumoral variation in HER2 levels of potential clinical relevance. Suitability for single-cell transcriptomic analysis was demonstrated for a triple-negative tumor core biopsy, revealing substantial cellular diversity in the tumor immune microenvironment, including a prognostically relevant T cell subpopulation. Thus, collection of fresh tissues for research purposes at the time of diagnostic breast biopsy is safe, feasible and efficient, and may provide a high-yield mechanism to generate a rich tissue repository for a wide variety of cross-disciplinary research.

Project description:INTRODUCTION:Chronic pain is highly prevalent, and the ability to routinely measure patients' pain and treatment response using validated patient-reported outcome (PRO) assessments is important to clinical care. Despite this recognition, systematic use in everyday clinical care is rare. AIMS:The aims of this study were to (1) describe infrastructure designed to automate PRO data collection, (2) compare study-enhanced PRO completion rates to those in clinical care, and (3) evaluate patient response rates by method of PRO administration and sociodemographic and/or clinical characteristics. SETTING:The Pain Program for Active Coping and Training (PPACT) is a pragmatic clinical trial conducted within three regions of the Kaiser Permanente health care system. PROGRAM DESCRIPTION:PPACT evaluates the effect of integrative primary care-based pain management services on outcomes for chronic pain patients on long-term opioid treatment. We implemented a tiered process for quarterly assessment of PROs to supplement clinical collection and ensure adequate trial data using three methods: web-based personal health records (PHR), automated interactive voice response (IVR) calls, and live outreach. PROGRAM EVALUATION:Among a subset of PPACT participants examined (n =?632), the tiered study-enhanced PRO completion rates were higher than in clinical care: 96% completed ??1 study-administered PRO with mean of 3.46 (SD?=?0.85) vs. 74% completed in clinical care with a mean of 2.43 (SD?=?2.08). Among all PPACT participants at 3 months (n =?831), PRO completion was 86% and analyses of response by key characteristics found only that participant age predicted an increased likelihood of responding to PHR and IVR outreach. DISCUSSION:Adherence to pain-related PRO data collection using our enhanced tiered approach was high. No demographic or clinical identifiers other than age were associated with differential response by modality. Successful ancillary support should employ multimodal electronic health record functionalities for PRO administration. Using automated modalities is feasible and may facilitate better sustainability for regular PRO administration within health care systems. Clinical Trials Registration Number: NCT02113592.

Dataset Information

The BMC Medicine breast cancer collection: an illustration of contemporary research and clinical care.

Publications

The BMC Medicine breast cancer collection: an illustration of contemporary research and clinical care.

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