The following is a list of the funded projects for 2014-2015.
Project #1: Personal Health Network Technology – Chemotherapy
PI: Jill Joseph, University of California, Davis
Project #2: A Nanopore-Nanofiber Mesh Biosensor
PI: Mark Grinstaff, Boston University, COE
Project #3: POC Tumor Marker Detection – Ovarian Tumors
PI: Justin Baca, University of New Mexico
Cancer patients in rural environments and of lower socioeconomic status face several barriers to accessing high quality, regionalized cancer care. Technologies that move tumor marker testing closer to the patient or to the oncologist’s office have the potential to improve access to care and quality of life for patients that must travel long distances for initial evaluations, surveillance visits, or routine cancer treatment. We are developing a point-of-care biosensor for detecting tumor markers for such patients. We will enable a Shear Horizontal Surface Acoustic Wave (SH-SAW) point-of-care sensor system for multiplexed tumor marker detection. While our system would be generalizable to detect any tumor marker with a specific monoclonal antibody, we propose to study tumor markers in ovarian germ cell and epithelial tumors as a model system.
Project #4: A New Wearable Technology – Chemotherapy Monitoring
PI: Darren Roblyer, Boston University, COE
Current chemotherapies and targeted agents for the treatment of solid tumors only extend life or provide cures in a fortunate subset of patients. Treatment success depends on a multitude of biological factors and any combination of non-ideal conditions will contribute to poor response rates and limited treatment efficacy, potentially leading to lengthy regimens that burden the health care system while providing little or no benefit to the patient. There are currently few clinically viable, cost-effective, non-invasive, and non-harmful methods of chemotherapy monitoring and there are no clinically accepted point-of-care (POC) chemotherapy monitoring methods.
Optical techniques such as Diffuse Optical Spectroscopy (DOS) are ideally suited for POC chemotherapy monitoring due to their favorable safety profiles and relative cost-effectiveness. Unfortunately, current DOS instruments have a large footprint (typically the size of a refrigerator) and often incorporate expensive benchtop electrical test equipment leading to total device costs between $50k and $70k. Here we propose two key technology developments necessary to transform DOS into a POC technique. The first is the development of an all-digital DOS measurement platform that will replace prior analog DOS systems. This will greatly reduce instrument footprint (to the size of a briefcase) and simplify overall system design. The second is the development of a new flexible and reusable DOS imaging pad that will collect DOS data from a large tissue field-of-view (FOV) without manual probe scanning. The pad will greatly improve measurement acquisition speed (estimated several seconds to measure a breast tumor compared with up to 1 hour for prior scanning technique), and importantly, will allow for continuous and real-time monitoring of patients during their chemotherapy infusions. Together, these two technology developments will lead to a new generation of portable and wearable digital Diffuse Optical Spectroscopy (dDOS) technology that is suited for POC measurements.
Project #5: Smartphone App for Chronic Pain Care – Cancer Patient
PI: Robert Jamison, Brigham and Women’s Hospital
This study is designed for cancer patients with chronic pain. Many of these patients are virtually homebound with limited support and mobility and may have pain from their disease or from past treatments. The overall aim of the study is to determine the effect of introducing a smartphone pain application (app) to chronic cancer-related pain patents who can assess, monitor, and communicate their status to their providers. To be useful, the components of this program need to be accurate, reliable, inexpensive, easy to use, timely, and acceptable to patients and clinicians. The goal is to introduce technology that will allow patients and physicians to more easily 1) identify factors exacerbating or relieving pain, 2) modify treatment, and 3) help patients to better understand and control their symptoms and symptom management. This study will serve to rigorously assess the outcome of a smartphone pain app. The hope is to gather information to refine the pain app for future use among persons with cancer-related chronic pain.
We will conduct a controlled trial by introducing a smartphone pain app to 20 chronic cancer-related pain patients randomly assigned to the Experimental group and compare outcome over 3 months with 20 patients who will receive treatment as usual (Control). The Smartphone Pain App is designed to monitor pain intensity, activity interference, mood, medication use, side effects and coping, as well as incorporate a body map for identifying the primary areas of pain. The program will also be interactive by offering education and suggestions as prompts in response to elevated ratings of pain, depression, sleep disturbances, etc. along the model of cognitive-behavioral therapy for pain. The program will summarize the patient’s progress and transmit this information to the providers via a link to a server at the Brigham and Women’s Hospital (BWH) Pain Management Center. We hope to learn about the best ways to use information technology in improving the quality of life among persons with cancer-related chronic pain.
Project #6: Topical Treatment of Oral Cancer
PI: Manijeh Goldberg, Privo Technologies, Inc.
Oral cancer (OC) is a complex, disabling, and potentially deadly subgroup of oncology. While its death rate is three times more than cervical cancer – it kills one person per hour per day in the US – it receives minor attention compared to other cancers such as skin or lung cancer. OC is considered an orphan disease (less than 200,000 patients) in the US. More than 50% of oral cancer patients die within the first 5 years of diagnosis due to cancer relapse and tumor recurrence. Chemo resistant recurrence is a major issue for oral cancer patients. This project suggests that local chemotherapy of oral cancer can improve patient outcome and can considerably reduce the systemic toxicity and it focuses on:
1) Can a local and topical chemotherapy reduce the chance of acquired chemo resistance compared to the current standard of care (Intravenous Chemotherapy)
2) Can resistant cancer tumors be destroyed with a high concentration of local chemotherapy without severe sideeffects
Project #7 Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors
PI: Lisa Quintiliani, Boston University, School of Medicine
Tremendous advances in detection and treatment of breast cancer have led to an increasingly large cohort of survivors focused on health promotion and reducing the risk of recurrence. While adjuvant therapy, such as hormone therapy, is often used to prevent cancer recurrence, modification of lifestyle behaviors is also an effective tool to increase quality of life, prevent future cancer recurrence and increase long-term health. However, translating these recommendations into population-wide, inexpensive, sustainable programs for cancer survivors has to date proven largely unrealized. These programs are particularly needed in health disparity-facing populations (i.e., low socio-economic status and/or racial/ethnic minority groups) due to the high burden of cancer incidence and mortality they face. Limited translation is due to many factors including the complexity of lifestyle habits, high patient burden of many behavioral interventions, low levels of engagement and adherence to interventions, and the lack of integration of behavior change tools into daily lifestyles. In this context, there is great promise of mHealth tools that are mobile, simple, and embedded into daily life routines. The long-term goal of this research program is to develop, evaluate and implement effective mHealth technology interventions that improve cancer management outcomes by changing lifestyle behaviors among urban health-disparity facing populations. The objective of the proposed study is to determine the feasibility and preliminary efficacy of an intervention, the mHealth counseling platform for cancer survivors, in which breast cancer survivors receive counseling about lifestyle behaviors (weight, nutrition, and physical activity) from patient navigators trained in evidenced-based behavioral counseling methods. The mHealth platform for cancer survivors has two primary components: 1) a smartphone app that captures patients’ behavioral data using intuitive self-tracking for diet intake and Bluetooth wireless sensors for weight and physical activity and 2) a web-based counseling portal through which navigators view and respond to patients’ behavioral data and assist them in setting goals for changing behaviors consistent with their cancer care plan. We will refine our existing platform (called Dash Mobile) to make it suitable for breast cancer survivors, perform usability testing on the new system, and then conduct a pilot trial in which 20 breast cancer survivors from Boston Medical Center (BMC) receive mHealth counseling. Completing this research will result in preliminary feasibility and efficacy data for a mHealth counseling approach for cancer-related behaviors among breast cancer survivors; forming the basis of a larger randomized efficacy trial and potential commercial vehicles to leverage this new platform.
The following is a list of the funded projects for 2012-2014.
Project #1 : Optical Spectroscopy for Improved PCP Screening of Colorectal Cancer
PI: Irving Bigio, Ph.D. (BU), Co-PI: Satish Singh, M.D. (BUSM, Boston VA Hospital)
The central objective of this project is to demonstrate the benefits of elastic scattering spectroscopy (ESS) as a pre-screening tool for colorectal cancer (CRC) at the primary-care physician (PCP) level. Recent studies at Northwestern University have demonstrated that a field effect of carcinogenesis (FEC) can be detected optically in endoscopically and histologically normal colorectal mucosa of patients harboring dysplasia/cancer (i.e., neoplasia) elsewhere in the colon. Our preliminary clinical studies indicate that ESS is also sensitive to the FEC, based on noninvasive optical measurements from the “normal” rectal or sigmoid mucosa, predicting the presence (or absence) of neoplastic polyps in proximal colonic segments. An optical measurement of the rectal/sigmoid mucosa that reliably predicts the presence of proximal adenomatous polyps, would dramatically alter clinical CRC screening and prevention paradigms. ESS offers the advantages of simplicity, low-cost and clinical friendliness, and enables the opportunity dramatically improve crc screeing in the PCP office. The goal is to demonstrate improvements in the screening and prevention of CRC compared to current standard practices. The potential impact on the health care system is profound, including greater CRC screening compliance and access, while lowering the overall cost burden.
Project #2: Improving Hepatocellular Carcinoma Patient Outcomes with a Novel Multiplexed Point-of-Care Biomarker Measurement System
PI: Daniel Laser, Ph.D. (wave80 Biosciences, Inc.), Co-PI: Catherine Klapperich, Ph.D. (BU)
This study focuses on new enclosed-cartridge-format assay methods and instrumentation for measurement of hepatocellular carcinoma (HCC) biomarkers. The program leverages a recently developed point-of-care molecular diagnostics assay platform, the EOSCAPE system, which uses singlet oxygen-catalyzed light emission and advanced assay cartridge technology to run sophisticated assays with turnaround times below 60 minutes. A new EOSCAPE cartridge is engineered to detect four proteins which, alone and in combination, are increasingly important in clinical management of patients at high risk for HCC and which require point-of-care measurement to facilitate timely clinical decision making. Prototype cartridges running the new assay will be tested in a clinical environment to assess performance incorporation into clinical workflow.
Project #3: miRNA Gel Pads for the Point of Care Detection of Lung Cancer Biomarkers in Serum
PI: Patrick Doyle, Ph.D. (MIT), Co-PI: Avrum Spira, M.D. (BUSM)
MicroRNAs (miRNAs) are short non-coding RNAs that are known to be dysregulated in many cancer types. With greater stability and predictive value than mRNA, this relatively small class of biomolecules has become increasingly important in determining disease diagnosis and prognosis. Despite their great promise, clinicians still lack the proper tools to routinely profile miRNA. In this project, we will develop a point of care fluidic chip capable of detecting multiple miRNA biomarkers for lung cancer directly in serum. We will validate the new technologies against existing sensing platforms and then move on to build a beta prototype. The new gel-pad technologies will be validated using both in-house and external testing platforms; on both synthetic and patient samples. Having validated the lab-based technique, the Doyle lab will work with the Fraunhofer Center for Manufacturing Innovation (FCMI) to build a prototype.
Project #4: Non-Enzymatic DNA Amplification Circuit for Cancer Biomarker Testing (melanoma)
PI: Andrew Ellington, Ph.D. (UT-Austin), Co-PI: Rhoda Alani, M.D. (BUSM)
Current molecular cancer diagnostics are not amenable to point-of-care testing. To effectively transition a molecular diagnostic testing into a point-of-care setting, we propose an integrated paperfluidic platform that will automate cancer biomarker testing in a manner similar to a classic diagnostic paper test-strip. We also propose to develop a hand-held electronic reader that further streamlines the already-simple sample analysis and produces a user-readable result as well as the possibility of wireless transmission of test results. The proposed system will combine extremely novel molecular techniques with mature, robust diagnostic technologies designed for point-of-care testing. Melanoma is responsible for the majority of deaths from skin cancer, and was the 6th most common cancer in the US in 2010. Histologic examination of early melanoma lesions is difficult and is not always predictive for malignant potential, which presenting clinical challenge. Encouragingly, recent studies have identified a panel of robust gene expression biomarkers that can be used to aid melanoma patient care. Circulating nucleic acid (CNA) consists of extracellular genetic material (DNA and RNA) freely found in human body fluids. These information-rich molecules of tumor-derived CNAs have a great potential as a noninvasive source of candidate biomarkers because they can be used to monitor the status of remote tumors, potentially bypassing the need for tissue biopsies. Using melanoma biomarkers as proofs-of principle, we propose to address this problem by incorporating gene expression-based and serum-based biomarker detection with an integrated solution for detection in limited-resource settings.
Project #5: My LifeCloud: A Mobile Based System Aimed at Empowering Patients who are at Risk for Colorectal Cancer
PI: Kelly Brittain, Ph.D. (Michigan State University, East Lansing, MI), Co-PI: Dr. Christos Cassandras (BU, Systems Engineering), Mr. Jose Gomez-Marquez (MIT)
Colorectal cancer is a major health threat for women. Colorectal cancer was once considered a “man’s disease” because the number of men diagnosed with colorectal cancer exceeded women 2:1. Since 2000, the number of women diagnosed with colorectal cancer has risen to equal that men. Colorectal cancer incidence and mortality rates for women have not changed in 5 years. A weapon in the fight against colorectal cancer is routine screening. If routine screening occurs, colorectal cancer is nearly preventable. Unfortunately, women aged 50-64 are less likely to have been screened for CRC within the recommended screening guidelines than those 65 and older. CRC screening rates are at 50% despite over 70% of women having insurance coverage for CRC screening. Previous interventions to address colorectal cancer screening such as postcards, public service announcements, and insurance coverage have not significantly improved colorectal cancer screening among women. New, innovative strategies are urgently needed to effectively increase CRC screening and reduce the colorectal cancer incidence and mortality rates among women. The purpose of this study is to explore the usability, acceptability, and satisfaction with and establish the effects of a mobile-based system designed to increase CRC screening intentions and behaviors among 50-64 year old women.