CTSI Translational Pilot Studies Program awards 13 new grants for 2020-21

Pregnancy is a unique opportunity to quit smoking, thus reversing the elevated risk of lung cancer due to cigarette or cigar smoking. However, most quitters return to smoking after delivery. In addition, while sufficient breastfeeding protects against breast cancer, smokers tend to not breastfeed. In this randomized controlled trial — the first of its kind — investigators will integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors among mostly socio-economically disadvantaged pregnant/postpartum women.

Opioids are widely prescribed across Western New York to manage pain, but misuse, abuse, and concurrent prescribing have contributed to a high number of adverse drug events. This pilot study involves a hybrid bio- and clinical-informatics approach in the prediction of opioid-related drug-drug interaction adverse events and validation on the WNY population using retrospective electronic health record data. The results will help identify drug combinations which result in high risk of negative outcomes, allowing clinicians to be better informed and avoid potentially life-threatening co-prescriptions.

Maternal hypercholesterolemia (MHC), an excessive increase in maternal cholesterol during pregnancy, is a pathological condition which leads to a variety of adverse pregnancy outcomes and predisposes offspring to a range of metabolic issues in adulthood. Little is known regarding the temporal changes in oxygenated derivatives of cholesterol — oxysterols — throughout pregnancy. In this study, investigators will evaluate the relationship of maternal oxysterol status during pregnancy on birth outcomes and neonatal health indices.

“Sofia Learns About Research” is an illustrated children's activity book designed to inform young readers about research including different types, the process of clinical research participation, the rights of research participants, and the importance of diverse representation in research. In phase 1 of the project the book will be disseminated in a novel fashion by creating and placing an electronic platform for youth and their families to view while visiting the Explore & More — The Ralph C. Wilson, Jr. Children’s Museum in Buffalo. In phase 2, data on the number of viewings and parental feedback of accompanying adults will be obtained. Preliminary data on the change in knowledge on research of school aged children pre- and post-visit to the museum will be assessed.

Hypertension (HTN) affected 85 million U.S. adults in 2014, a figure projected to reach 95 million by 2030. A 2017 report called for research on the microbiome’s role in blood pressure (BP) regulation and HTN. If an etiologic link between the microbiome composition and BP is established, and if this microbiome is measurable in saliva, there are enormous translational implications for development of a screening modality using saliva. This study will establish the feasibility of using next generation sequencing technology to measure the microbiome in human saliva samples from postmenopausal women.

African Americans are 3.7 times more likely than whites to have end-stage renal disease (ESRD) yet are 24% less likely than whites to receive a kidney transplant. The inequitable provision of transplant information is a persistent factor contributing to this disparity. In response to this need, investigators have developed eKIDNEY, a mobile self-education program for African American ESRD patients and their family and friends. This study aims to assess patient and social network feasibility and acceptability of eKIDNEY, determine its usability as an individually adapted intervention, and obtain preliminary indicators of its effectiveness.

The five-year survival rate for pancreatic adenocarcinoma (PDAC) remains under 10%, the same as it was over 30 years ago. Pancreatic cancer has been considered “undruggable” because the four mutated genes that drive their cancer progression are poor drug targets. This study seeks to identify new drugs that target critical genes and pathways required for pancreatic cancer cell survival and/or proliferation. Investigators will use a technique that rapidly identifies which genes and pathways are essential for pancreatic cancer cell progression, then link these to drug susceptibilities.

Triple negative breast cancer (TNBC) is the most aggressive and lethal subtype of breast cancer. The standard of care of early stage TNBC is neoadjuvant chemotherapy with anthracycline and taxane, with only 25-35% complete pathological responses (pCR) followed by surgery and local radiation therapy. Although TNBC is generally chemo-sensitive, it has a very high risk of relapse in patients. In this study, investigators will conduct correlative analysis on blood and tumor samples from early stage TNBC patients, combining chemokine modulation regimen with neoadjuvant chemotherapy to improve pCR.

Ultra-slow waves on the nanoscale offer a unique potential for boosted light-matter interaction in nanoplasmonic structures. In particular, trapped “rainbow” storage of light in metamaterials and plasmonic graded structures have opened up a new approach to manipulate light on a chip. This project will develop a powerful miniaturized imaging-based spectrometer and reveal its potential in super-resolution identification of spatial pattern shift for surface biosensing. Realization of this low-cost, miniaturized optical system could yield important technological breakthroughs in biosensing and biomedical investigations.

Investigators in this study hypothesize that the identification of neutrophil extracellular trap products in the plasma (NETosis) of pancreatic ductal adenocarcinoma (PDAC) patients will identify a subset with high risk of thrombosis and poor outcomes, for which prophylactic anticoagulation will have a meaningful benefit. Investigators aim to develop a plasma NETosis signature to identify patients with PDAC with the highest risk for thrombosis and predict benefit from this intervention in terms of decreasing thrombosis risk and improving overall survival.

Subarachnoid hemorrhage after brain aneurysm rupture has profound impact due to high morbidity and mortality. Tremendous resources are expended in anticipation of potential complications like vasospasm and delayed cerebral ischemia. But our ability to predict which patients will develop these conditions to target resources is poor. Investigators in this study have developed predictive models and propose to further refine and validate those models using a local cohort of aneurysm patients treated at the Gates Vascular Institute in Buffalo.

Currently available targeted therapies are ineffective in triple negative breast cancer (TNBC), creating an urgent need to identify novel targets and develop new therapeutic strategies. Recent studies have revealed that Tamoxifen increases interactions between ERβ and mutant p53 in TNBC cells, resulting in the reactivation of tumor suppressor p73 leading to tumor cell apoptosis. Investigators hypothesize that Tamoxifen — currently not used to treat TNBC — can be repurposed in combination with Doxorubicin to treat TNBC based on the expression of ERβ and mutant p53.

Debilitating pain in the female vulvar region, known as vulvodynia, affects up to 30% of women at some point in their lives. Despite the high prevalence and devastating consequences of the condition, little is known about its etiology, and treatment follows a heuristic approach with no clear guidelines. Investigators in this study are developing the “Vulvodyne,” a prototype device to provide a diagnostic and imaging tool for vulvodynia. Regions of sensitivity in women with vulvodynia can be imaged thermally and optically, and these images can be quantitatively analyzed to determine the severity and extent of vulvodynia. Objective information obtained in this manner can then be utilized to monitor symptom progression and response to treatment.